What is the recommended dosing strategy and supporting clinical evidence for subcutaneous unfractionated heparin for VTE prophylaxis in patients with obesity?

Comment by InpharmD Researcher

Although an ideal dosing regimen for VTE prophylaxis in obese patients has not been established, limited data collected from guidelines and review articles suggest using unfractionated heparin (UFH) 7,500 units Q8H in patients with a body mass index ≥40 kg/m2. Previous recommendations had utilized 5,000 units UFH Q8H for VTE prophylaxis in critically ill obese patients; however, in more extreme obesity (BMI ≥ 50 kg/m2), 7,500 units of UFH Q8H may be considered. While much of the literature supports the use of fixed dosing in obese patients, some clinical data regarding the exact regimen are conflicting, indicating that there is insufficient data to definitively recommend a single strategy.

Pubmed: unfractionated heparin VTE prophylaxis obesity (218 results) Scholar: unfractionated heparin VTE prophylaxis obesity (14,600 results)

Background

The 2012 American College of Chest Physicians (ACCP) guidelines for the prevention of VTE in nonsurgical patients recommend for acutely ill hospitalized medical patients who are at increased risk of thrombosis to be on anticoagulant thromboprophylaxis with low-molecular-weight heparin (LMWH), low-dose unfractionated heparin (LDUH) twice daily, LDUH three times daily, or fondaparinux. The recommended prophylaxis dose for unfractionated heparin is 5000 units twice or three times daily; there is no distinct recommendation on doses for patients who are obese. [1], [2]

A 2016 review in response to the 2012 ACCP guidelines examined different chemical prophylaxis to prevent venous thromboembolism in morbidly obese patients (BMI > 40 kg/m2) since the specific patient population is not defined in previous ACCP guidelines. The paper concludes that if unfractionated heparin (UFH) is used, then the recommended dose is 7,500 units SQ TID (increased from 5,000 units BID to TID). The review advises using prophylactic doses of subcutaneous UFH in morbidly obese patients who also have renal impairment (CrCl <30 mL/min) instead of enoxaparin. [3]

A 2021 review evaluating drug dosing in critically ill obese patients discussed commonly used medications in the intensive care unit (ICU) for hemodynamic support or prophylaxis. Regarding VTE prophylaxis, studies assessing UFH dosing regimens for VTE prophylaxis in obese patients have mostly found no difference in VTE rates between standard and elevated doses. Therefore, 5,000 units UFH Q8H may be appropriate for VTE prophylaxis in critically ill obese patients; however, in more extreme obesity (BMI ≥ 50 kg/m2), 7,500 units of UFH Q8H may be considered. [4]

Due to the under-representation of obese patients in clinical trials, there are uncertainties regarding the optimal dosing for both safety and efficacy. Pharmacokinetic studies and small-scale cohort studies, which serve as the basis for current knowledge, suggest that weight-based dosing of UFH and LMWH is generally preferable over fixed dosing in obese patients for VTE treatment and prophylaxis. [5]

A 2021 systematic review and meta-analysis comprehensively evaluated the efficacy and safety of weight-adjusted versus fixed-dose heparin for VTE prevention in hospitalized obese patients. The analysis encompassed 12 studies, including prospective observational, retrospective, non-randomized, and randomized controlled trials, focusing on the occurrence of VTE, bleeding events, and anti-Xa levels. The review covered both LMWH and UFH regimens, with doses adjusted based on weight compared to standard fixed doses, such as the administration of enoxaparin 40 mg or heparin 5000 units. The studies involved a total of over 13,000 patients, detailing outcomes across various settings, including medical and surgical wards. The meta-analysis found no significant reduction in VTE occurrence with weight-adjusted heparin doses compared to fixed-dose regimens (odds ratio [OR] 1.03, 95% confidence interval [C.I.] 0.79 to 1.35). Additionally, bleeding risks were not significantly increased with weight-adjusted dosing (OR 0.84, 95% C.I. 0.65 to 1.08). However, weight-adjusted dosing was associated with higher anti-Xa levels (effect size [ES] 2.04, 95% C.I. 1.16 to 2.92, p<0.0001). Despite the higher anti-Xa levels, the study did not establish a direct clinical benefit in terms of VTE reduction or bleeding risk. The findings suggest that a fixed-dose heparin strategy might be sufficient for VTE prophylaxis in obese patients, without necessitating weight adjustments, which challenges existing practices of using weight-adjusted dosing in this population. [6]

A 2019 review found conflicting evidence (see Table 1) regarding the use of higher fixed doses of UFH for VTE prophylaxis in obese patients. Subjects were largely hospitalized patients without specifically identifying the critically ill population. The event rates for both VTE and bleeding complications varied widely across the included studies which further makes it difficult to formally conclude the outcomes of treatment with either treatment strategy. Overall, the authors concluded that there is insufficient data to recommend routine use of high-dose thromboprophylaxis in obese patients. [7]

Similarly conflicting results were found in a 2020 retrospective audit, however, which evaluated the dosing practices of UFH in obese patients at the Princess Alexandra Hospital in Queensland, Australia. The investigation analyzed 200 patients, divided into weight cohorts of <100 kg, 100–124.9 kg, 125–150 kg, and >150 kg, to determine if the current dosing practices led to inadequate anticoagulation. The primary outcome focused on the mean maintenance doses required to achieve two consecutive therapeutic activated partial thromboplastin times (APTTs) and the time to reach this endpoint. Results indicated that the mean maintenance doses in units per hour (U/h) increased consistently with weight, with doses of 1229±316, 1673±523, 2031±596, and 2146±846 U/h required for the respective weight cohorts. Interestingly, the weight-based doses in units per kilogram per hour (U/kg/h) showed a decreasing trend as weight increased, amounting to 16±4.1, 15.1±4.8, 14.9±4.2, and 11.6±4.2 for the cohorts, respectively. The 2020 audit revealed that the median time to achieve therapeutic APTTs was notably prolonged, with obese patients requiring 39 hours on average, suggesting that the dosing practices might be inadequate. A significant finding was the increased need for larger absolute doses of UFH (U/h) in obese patients, indicating that current nomograms based on total body weight might lead to underdosing when capped doses are applied. The investigation advises considering larger absolute doses but lower uncapped TBW-based doses as weight increases. The study underscores the need for revising UFH dosing strategies in obese populations to ensure timely and adequate anticoagulation, thereby advocating for larger doses that align with the pharmacokinetic and pharmacodynamic profiles observed in obese patients. Future research should focus on prospective trials to validate these findings and evaluate the clinical outcomes associated with modified dosing regimens. [8]

References: [1] Garcia DA, Baglin TP, Weitz JI, Samama MM. Parenteral anticoagulants: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines [published correction appears in Chest. 2012 May;141(5):1369. Dosage error in article text] [published correction appears in Chest. 2013 Aug;144(2):721. Dosage error in article text]. Chest. 2012;141(2 Suppl):e24S-e43S. doi:10.1378/chest.11-2291
[2] Kahn SR, Lim W, Dunn AS, et al. Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e195S-226S.
[3] Vandiver JW, Ritz LI, Lalama JT. Chemical prophylaxis to prevent venous thromboembolism in morbid obesity: literature review and dosing recommendations. J Thromb Thrombolysis. 2016;41(3):475-81.
[4] Erstad BL, Barletta JF. Drug dosing in the critically ill obese patient: a focus on medications for hemodynamic support and prophylaxis. Crit Care. 2021;25(1):77. Published 2021 Feb 23. doi:10.1186/s13054-021-03495-8
[5] Ihaddadene R, Carrier M. The use of anticoagulants for the treatment and prevention of venous thromboembolism in obese patients: implications for safety. Expert Opin Drug Saf. 2016;15(1):65-74. doi:10.1517/14740338.2016.1120718
[6] Ceccato D, Di Vincenzo A, Pagano C, Pesavento R, Prandoni P, Vettor R. Weight-adjusted versus fixed dose heparin thromboprophylaxis in hospitalized obese patients: A systematic review and meta-analysis. Eur J Intern Med. 2021;88:73-80. doi:10.1016/j.ejim.2021.03.030
[7] Lewis TC, Cortes J, Altshuler D, Papadopoulos J. Venous Thromboembolism Prophylaxis: A Narrative Review With a Focus on the High-Risk Critically Ill Patient. J Intensive Care Med. 2019;34(11-12):877-888. doi:10.1177/0885066618796486
[8] George C, Barras M, Coombes J, Winckel K. Unfractionated heparin dosing in obese patients. Int J Clin Pharm. 2020;42(2):462-473. doi:10.1007/s11096-020-01004-5
Literature Review

A search of the published medical literature revealed 9 studies investigating the researchable question:

What is the recommended dosing strategy and supporting clinical evidence for subcutaneous unfractionated heparin for VTE prophylaxis in patients with obesity?

Level of evidence

B - One high-quality study or multiple studies with limitations  Read more→



Please see Tables 1-9 for your response.


 

High-Dose Thromboprophylaxis in Obese, Hospitalized Patients1

Study Design

Patient Population Treatment Comparator VTE Incidence  Bleeding Incidence Comments
Multicenter, retrospective cohort study

Hospitalized patients weighing > 100 kg

UFH 7,500 units TID or enoxaparin 40 mg BID UFH 5,000 units BID to TID or enoxaparin 40 mg QD

Unadjusted analysis:

  • SD: 1.52%, HD: 1.18%, p= 0.22

BMI < 40 kg/m2: SD: 1.54%, HD: 1.88% (OR: 1.23, 95% CI: 0.72-2.10, p= 0.46)

BMI ≥ 40 kg/m2: SD: 1.48%, HD: 0.77% (OR: 0.52, 95% CI: 0.27-1.00,  p= 0.05)

BMI < 40 kg/m2: SD: 8.52%, HD: 6.87% (OR: 0.79, 95% CI: 0.60-1.05, p= 0.10)

BMI ≥ 40 kg/m2: SD: 8.44%, HD: 7.18% (OR: 0.84, 95% CI: 0.66-1.07, p= 0.15)

 

Included all hospitalized patients

Median BMI of 39 kg/m2

Used both UFH and enoxaparin

Low incidence of VTE

Single-center, retrospective observational study Hospitalized patients weighing > 100 kg UFH 7,500 units TID UFH 5,000 units TID

All VTE: SD: 1.5%, HD: 3%, p= 0.14

Pulmonary embolism: SD: 0.2%, HD: 0.9%, p= 0.08

Hgb drop ≥ 2 g/dL over 24 h: SD: 7%, HD: 10%, p< 0.01

Hgb drop ≥ 2 g/dL from admission: SD: 18%, HD: 27%, p= 0.09

≥ 2 units PRBCs transfused: SD: 8%, HD: 11%, p= 0.04

 

Included all hospitalized patients

BMI significantly higher in HD group

Low incidence of VTE

Single-center, retrospective cohort study Hospitalized, obese patients (BMI ≥ 30 kg/m2) UFH 7,500 units TID UFH 5,000 units TID All VTE: SD: 0.23%, HD: 1.02%, p= 0.05

No major bleeding

Minor bleeding: SD: 0.09%, HD: 0%, p= 0.67

Included all hospitalized patients

HD group 3x more likely to be admitted to ICU

No comparison of BMI between groups

Low incidence of VTE and bleeding

Single-center, retrospective observational study

Neurosurgical ICU patients weighing > 100 kg

UFH 7,500 units TID UFH 5,000 units TID All VTE: SD: 9.3%, HD: 5.7%, p= 0.20

Hgb drop ≥ 2 g/dL over 24 h: SD: 11%, HD: 14%, p= 0.33

Hgb drop ≥ 2 g/dL from admission: SD: 51%, HD: 57%, p= 0.24

PRBCs transfused: SD: 20%, HD: 26%, p= 0.22

Body weight significantly higher in HD group

Significant differences in time to initiation of VTE prophylaxis

Abbreviations: BID, twice daily; BMI, body mass index; CI, confidence interval; HD, high dose; Hgb, hemoglobin; ICU, intensive care unit; OR, odds ratio; PRBC, packed red blood cells; QD, once daily; SD, standard-dose; TID, 3 times daily; UFH, unfractionated heparin; VTE, venous thromboembolism.     

 

References:
[1] Lewis TC, Cortes J, Altshuler D, Papadopoulos J. Venous Thromboembolism Prophylaxis: A Narrative Review With a Focus on the High-Risk Critically Ill Patient. J Intensive Care Med. 2019;34(11-12):877-888. doi:10.1177/0885066618796486
[2] Wang TF, Milligan PE, Wong CA, Deal EN, Thoelke MS, Gage BF. Efficacy and safety of high-dose thromboprophylaxis in morbidly obese inpatients. Thromb Haemost. 2014;111(1):88-93. doi:10.1160/TH13-01-0042
[3] Joy M, Tharp E, Hartman H, et al. Safety and Efficacy of High-Dose Unfractionated Heparin for Prevention of Venous Thromboembolism in Overweight and Obese Patients. Pharmacotherapy. 2016;36(7):740-748. doi:10.1002/phar.1775
[4] Beall J, Woodruff A, Hempel C, Wovkulich M, Zammit K. Efficacy and Safety of High-Dose Subcutaneous Unfractionated Heparin Prophylaxis for the Prevention of Venous Thromboembolism in Obese Hospitalized Patients. Hosp Pharm. 2016;51(5):376-381. doi:10.1310/hpj5105-376
[5] Samuel S, Iluonakhamhe EK, Adair E, et al. High dose subcutaneous unfractionated heparin for prevention of venous thromboembolism in overweight neurocritical care patients. J Thromb Thrombolysis. 2015;40(3):302-307. doi:10.1007/s11239-015-1202-x

Efficacy of standard dose unfractionated heparin for venous thromboembolism prophylaxis in morbidly obese and non-morbidly obese critically ill patients

Design

Retrospective, single-center, observational, cohort study

N= 3,056

Objective

To determine the efficacy of standard dose unfractionated heparin (UFH) for venous thromboembolism (VTE) prophylaxis in critically ill morbidly obese patients

Study Groups

BMI < 40 kg/m2 (n= 2,813)

BMI ≥ 40 kg/m(n= 243)

Inclusion criteria

18 years of age or older, admittance to the ICU, receipt of standard-dose UFH (5,000 units subcutaneously twice daily or three times daily) for VTE prophylaxis in the ICU

Exclusion criteria

Patients who received non-standard doses of UFH, had missing weight or height information

Methods

This was a retrospective study that utilized a large database of ICU patients and evaluated VTE incidence in patients receiving standard-dose UFH with a BMI ≥ 40 kg/m2 versus those with a BMI < 40 kg/m2. A standard dose of UFH was used, which was measured as a secondary endpoint.

Duration

2001 to 2008

Outcome Measures

Primary outcome: VTE incidence during hospitalization

Secondary outcomes: VTE incidence among different BMI categories (BMI < 30 kg/ m2, BMI 30–40 kg/m2, BMI 40–50 kg/m2, and BMI > 50 kg/m2), average daily dose of UFH per weight, hospital length of stay in days, ICU length of stay in days

Baseline Characteristics

 

BMI < 40 kg/m2 (n= 2,813)

BMI ≥ 40 kg/m(n= 243)

 

Age, years

65.15 ± 17.66 56.65 ± 13.40  

Male

1,656 (59%) 121 (50%)  

Female

1,157 (41%) 122 (50%)  

BMI, kg/m2

27.15 ± 5.15

47.75 ± 9.18

 

UFH regimen

BID

TID

 

822 (29%)

1,991 (71%)

 

34 (14%)

209 (86%)

 

Results

 

BMI < 40 kg/m2 (n= 2,813)

BMI ≥ 40 kg/m(n= 243)

P-value

VTE Incidence

59 (2.1%)  7 (3%) 0.11

Average UFH daily dose per weight, units/kg/day

181 ± 53

111 ± 26

<0.001

Hospital length of stay, days

14 ± 14

 17 ± 16 0.016

ICU length of stay, days

8±11

 10±11 0.007

VTE Incidence among different BMI groups: BMI < 30 kg/ m(38/2,016, 1.9%); BMI 30–40 kg/m2 (20/797, 2.5%); BMI 40–50 kg/m2 (6/185, 3.2%); BMI > 50 kg/m2 (3/58, 5.2%) 

0.049

Adverse Events

Not reported

Study Author Conclusions

Morbid obesity was not associated with an increased VTE incidence in patients treated with standard-dose UFH in the ICU. However, as BMI increases, so does the risk of VTE occurrence and the likelihood of patients experiencing longer hospital and ICU length of stay. Due to differences in our population’s baseline characteristics, further studies should be conducted with well-balanced baseline characteristics. In addition, there may exist gender-specific differences for VTE incidence in morbidly obese patients which warrants further investigation.

InpharmD Researcher Critique

The population size for BMI ≥ 40 kg/mgroup was relatively small compared to BMI < 40 kg/m2 group. UFH is commonly chosen for VTE prophylaxis in critically ill patients with renal impairment or failure because it is not accumulated in the kidneys, which is commonly identified in the ICU. However, the authors do not report how many patients, if any, had renal impairment.

References:
[1] Lee YR, Blanco DD. Efficacy of standard dose unfractionated heparin for venous thromboembolism prophylaxis in morbidly obese and non-morbidly obese critically Ill patients. J Thromb Thrombolysis. 2017;44(3):386-391.

 

Safety and Efficacy of High-Dose Unfractionated Heparin Versus High-Dose Enoxaparin for Venous Thromboembolism Prevention in Morbidly Obese Hospitalized Patients

Design

Single-center, retrospective, observational study

N= 305

Objective

To investigate whether patients who received high-fixed dose unfractionated heparin (UFH) versus enoxaparin (low-molecular-weight heparin; LMWH) would have a significantly higher incidence of major bleeding along with the difference in the incidence of venous thromboembolism (VTE) diagnosed during hospitalization

Study Groups

UFH (n= 190)

LMWH (n= 115)

Inclusion Criteria

Age 18 years or older, admitted for at least 48 hours, body mass index (BMI) ≥ 40 kg/m2, received at least 3 consecutive doses of UFH or LMWH

Exclusion Criteria

VTE diagnosis within 48 hours of admission, pregnancy/peripartum, thrombocytopenic, acquired or hereditary coagulopathy diagnosis identified on admission

Methods

Patient data was collected from a U.S. single-center electronics database. Patients included must have received at least 3 consecutive doses of UFH 7500 units SubQ Q8H or enoxaparin 40 mg SubQ Q12H during hospitalization. 

Duration

Data collection: May 1, 2014 to April 30, 2018

Outcome Measures

Primary: incidence of major bleeding events (International Society of Thrombosis and Haemostasis major bleeding criteria for nonsurgical patients: Hgb decrease by ≥ 2 g/dL from baseline and needing ≥ 2 units of packed red blood cells), incidence of VTE diagnosis during hospitalization

Secondary: suspected and confirmed heparin-induced thrombocytopenia (HIT), missed VTE prophylaxis doses

Baseline Characteristics

 

UFH (n= 190)

LMWH (n= 115)

   

Age, years

57.5 50    

Female

67.4% 70.4%    

Race

African American

Caucasian

Other

 

57.4%

34.7%

4.2%

 

36.5%

54.8%

7.8%

   

Weight, kg

BMI, kg/m2

136.98 ± 26.13

48.74 ± 8.43

144.78 ± 31.03

50.68 ± 9.49

   

Creatinine clearance, mL/min

85.99 ± 34.08

108.1 ± 16.33

   

Concomitant antiplatelet use

42.6%

26.9%

   

Results

Endpoint

UFH (n= 190)

LMWH (n= 115)

Odds ratio (OR) (95% confidence interval [CI])

p-value

Major bleeding event

Hgb decrease by ≥ 2 g/dL

≥ 2 units of packed red blood cells used

Critical site bleeding

62 (32.6%)

61 (32.1%)

6 (3.2%)

0

24 (20.9%)

24 (20.9%)

0

1 (0.9%)

1.85 (1.07 to 3.13)

0.025

0.032

0.017

0.162

VTE event

Deep-vein thrombosis

Pulmonary embolism

4 (2.1%)

3 (1.6%)

1 (0.5%)

1 (0.9%)

0

1 (0.9%)

2.45 (0.27 to 22.22)

0.388

0.091

0.723

Suspected HIT

Confirmed HIT

1 (0.5%)

0

0

0

--

0.33

--

Percent missed VTE prophylaxis doses

9.9% ± 9.0%

12.6% ± 8.3%

-- 0.004

Study Author Conclusions

High-fixed dose unfractionated heparin for venous thromboembolism prophylaxis may lead to a higher risk of major bleeding events compared with high-fixed dose enoxaparin in patients who are morbidly obese.

InpharmD Researcher Critique

Due to the retrospective nature of the study, there was no formal study protocol regarding the choice of prophylactic agent. Noticeably, there are factors that may predispose a clinician to choose UFH or LMWH (e.g., patient's age, creatinine status, need for surgery, etc.) which may influence the type of care received along with the outcome of patients. Enoxaparin also requires dose reduction in renally impaired patients, but the guidance for high-fixed dosing in morbidly obese patients is not clear.  Additionally, patients prescribed UFH had a higher incidence of concomittent anti-platelet therapy than those with LMWH (42.6% vs 26.9%) which may affect the rate of bleeding events.



References:
[1] Mason SW, Barber A, Jones E, Chen SL, Moll S, Northam K. Safety and Efficacy of High-Dose Unfractionated Heparin Versus High-Dose Enoxaparin for Venous Thromboembolism Prevention in Morbidly Obese Hospitalized Patients. Am J Med. 2020;133(6):e249-e259. doi:10.1016/j.amjmed.2019.12.003

Efficacy and safety of high-dose thromboprophylaxis in morbidly obese inpatients

Design

Retrospective cohort study

N= 9,241

Objective

To quantify the efficacy and safety of high-dose thromboprophylaxis with heparin or enoxaparin in inpatients with weight >100 kg within a single healthcare system 

Study Groups

BMI <40 kg/m² (n= 5,313) 

BMI ≥40 kg/m² (n= 3,928)

Inclusion criteria

Weight >100 kg and body mass index (BMI ≥40 kg/m²)

Exclusion criteria

CrCl <30 mL/min, patients with missing height or weight, under 18 years of age, had a medication order for VTE treatment within the first 48 hours of admission

Methods

Patients received either high-dose thromboprophylaxis (heparin 7,500 units TID or enoxaparin 40 mg BID) or standard doses (heparin 5,000 units BID or TID or enoxaparin 40 mg once daily).

Duration

2010 to 2012

Outcome Measures

In-hospital VTE, bleeding events

Baseline Characteristics

 

VTE (n= 132)

No VTE (n= 9,109)

Age, years

57.1  54.3 

Weight, kg

119.8 118.6

BMI, kg/m²

38.7 39.6

Female 

34 (25.8%) 3,870 (42.5%)

Non-Caucasian Race

19 (14.4%) 2,378 (26.1%)

Length of stay, days

13.4 4.3

Results

 

VTE  Bleeding

BMI <40 kg/m² (n= 5,313)

Standard dose

High dose

p-value

 

68 (1.54%)

17 (1.88%)

0.46

 

376 (8.52%)

62 (6.87%)

0.10

BMI ≥40 kg/m² (n= 3,928)

Standard dose

High dose

p-value

 

35 (1.48%)

12 (0.77%)

0.05

 

200 (8.44%)

112 (7.18%)

0.15

Adverse Events

N/A

Study Author Conclusions

High-dose thromboprophylaxis nearly halves the rate of VTE in morbidly obese inpatients.

InpharmD Researcher Critique

The strength of the study is a large sample size with well-defined clinical outcomes. However, this study is limited by its retrospective study design and uneven lengths of stay or follow-up.

References:
[1] Wang TF, Milligan PE, Wong CA, Deal EN, Thoelke MS, Gage BF. Efficacy and safety of high-dose thromboprophylaxis in morbidly obese inpatients. Thromb Haemost. 2014;111(1):88-93.

Heparin dosing for venous thromboembolism prophylaxis in obese hospitalized patients: An observational study
Design

Retrospective cohort study

N= 5110

Objective To compare rates of VTE occurrence in obese versus non-obese hospitalized patients who received UFH 5000 units subcutaneously q8 h
Study Groups

Obese (n= 1673)

Non-obese (n= 3437)

Inclusion Criteria Adult patients hospitalized during 2015 receiving UFH 5000 units subcutaneously q8 h for VTE prophylaxis
Exclusion Criteria Patients with a VTE present on admission
Methods A retrospective analysis was conduceted of adult patients receiving UFH 5000 units SC q8 h for VTE prophylaxis. Data were obtained from hospital databases, including patient demographics, comorbidities, and outcomes. Patients were categorized as obese (BMI ≥30 kg/m2) or non-obese (BMI <30 kg/m2).
Duration January 2015 to December 2015
Outcome Measures

Primary: Occurrence of VTE during hospitalization

Secondary: Occurrence of significant bleeding (intracranial and gastrointestinal hemorrhage)

Baseline Characteristics   Non-obese (N = 3437) Obese (N = 1673)
Age, years 58 ± 19 55 ± 16
Male 1976 (58%) 781 (47%)
Body mass index, kg/m2 24 ± 4 37 ± 8

Race

White

Hispanic

 

2000 (58%)

1155 (34%)

 

785 (47%)

777 (46%)

Service

General medicine

General surgery

Cardiology

 

1765 (51%)

275 (8%)

244 (7%)

 

835 (50%)

185 (11%)

149 (9%)

Charlson comorbidity index

0

1

2+

 

1334 (39%)

688 (20%)

1415 (41%)

 

582 (35%)

317 (19%)

774 (46%)

Results   Non-Obese (N = 3437) Obese (N = 1673) p-value
VTE occurrence, no. (%) 19 (0.6) 11 (0.7) 0.70
Intracranial hemorrhage, no. (%) 2 (0.1) 3 (0.2) 0.34
Gastrointestinal hemorrhage, no. (%) 13 (0.4) 6 (0.4) >0.99
Adverse Events Intracranial bleeding occurred in 0.2% of obese patients and 0.1% of non-obese patients. Gastrointestinal bleeding occurred in 0.4% of both obese and non-obese patients
Study Author Conclusions UFH 5000 units subcutaneously q8 h may be sufficient for prevention of VTE in obese patients.
Critique The study's retrospective design limits the ability to establish causality. The reliance on ICD-9-CM coding may affect the accuracy of outcome identification. The study did not account for non-pharmacological VTE prophylaxis methods, which could influence results. Additionally, the study's findings may not be generalizable to patients with extreme obesity (BMI ≥60 kg/m2) due to the small number of such patients in the cohort.
References:
[1] Patanwala AE, Seaman SM, Kopp BJ, Erstad BL. Heparin dosing for venous thromboembolism prophylaxis in obese hospitalized patients: An observational study. Thromb Res. 2018;169:152-156. doi:10.1016/j.thromres.2018.07.027

Effectiveness, safety, and costs of thromboprophylaxis with enoxaparin or unfractionated heparin in inpatients with obesity
Design Retrospective cohort study N= 67,193
Objective To compare clinical and economic outcomes among adult medical inpatients with obesity who received thromboprophylaxis with enoxaparin or unfractionated heparin (UFH)
Study Groups

Enoxaparin (n= 44,367)

UFH (n= 22,826)

Inclusion Criteria Patients ≥18 years old, primary or secondary discharge diagnosis of obesity, received ≥1 thromboprophylactic dose of enoxaparin (≤40 mg/day) or UFH (≤15,000 IU/day), stayed ≥6 days in the hospital, discharged between 01 January 2010, and 30 September 2016
Exclusion Criteria Surgical patients, patients with pre-existing VTE, those who received higher doses or multiple types of anticoagulants
Methods Retrospective analysis using the PINCAITM Healthcare Database. Multivariable regression models compared enoxaparin with UFH based on VTE incidence, PE-related mortality, in-hospital mortality, major bleeding, treatment costs, and total hospitalization costs during the index hospitalization and 90 days after discharge
Duration January 2010 to September 2016
Outcome Measures

Primary: Incidence of VTE, PE-related mortality, in-hospital mortality, major bleeding

Secondary: Treatment costs, total hospitalization costs

Baseline Characteristics   Enoxaparin (n= 44,367) Unfractionated heparin (n= 22,826)
Age, years 59 ± 14 61 ± 14
Female 61% 55%
White 72% 67%
Medicare 51% 55%
ICU admission 27% 35%
Hospital length of stay, days 8.6 ± 4.3 9 ± 4.9
Results   Enoxaparin (n= 44,367) Unfractionated heparin (n= 22,826) Adjusted OR (95% CI)
VTE event 0.48% 0.85% 0.71 (0.57–0.88)
In-hospital mortality 2.34% 4.38% 0.70 (0.63–0.78)
PE-related mortality 0.02% 0.11% 0.27 (0.17–0.61)
Major bleeding 1.72% 3.5% 0.61 (0.55–0.69)
Adverse Events Major bleeding was significantly lower in the enoxaparin group (1.72%) compared to the UFH group (3.5%)
Study Author Conclusions Among adult inpatients with obesity, primary thromboprophylaxis with enoxaparin compared with UFH was associated with significantly lower risks of in-hospital VTE, major bleeding, PE-related mortality, overall in-hospital mortality, and hospitalization costs
Critique The study's large sample size and use of a comprehensive database are strengths, but its retrospective design may introduce selection bias. The reliance on ICD codes for obesity and outcomes may lead to misclassification. Additionally, the lack of BMI data limits the ability to assess outcomes in patients with severe obesity
References:
[1] Amin A, Kartashov A, Ngai W, Steele K, Rosenthal N. Effectiveness, safety, and costs of thromboprophylaxis with enoxaparin or unfractionated heparin in inpatients with obesity. Front Cardiovasc Med. 2023;10:1163684. Published 2023 Jun 16. doi:10.3389/fcvm.2023.1163684

Safety and Efficacy of High-Dose Unfractionated Heparin for Prevention of Venous Thromboembolism in Overweight and Obese Patients
Design

Single-center, retrospective, observational cohort study

N= 1335

Objective To determine the safety and efficacy of high-dose subcutaneous unfractionated heparin (UFH) for prevention of venous thromboembolism (VTE) in overweight and obese patients
Study Groups

High-dose group (n= 751)

Low-dose group (n= 584)

Inclusion Criteria Adult patients (≥ 18 years old) admitted between January 1, 2013, and August 31, 2014, weighing over 100 kg on admission, receiving either subcutaneous UFH 5000 units or 7500 units every 8 hours for VTE prevention
Exclusion Criteria Patients admitted with VTE, requiring anticoagulation, with a history of or diagnosed with atrial fibrillation, hospital stay <48 hours, or received enoxaparin for VTE prophylaxis
Methods Patients received either subcutaneous UFH 7500 units every 8 hours (high-dose) or 5000 units every 8 hours (low-dose) for VTE prophylaxis. Patients were categorized into BMI groups: overweight, obese class I, II, and III. Healthy weight was deemed as BMI of 18.5 to < 25 kg/m2; overweight was 25 to less than 30 kg/m2, obesity class I was 30 to < 35 kg/m2 and class II was 35 to < 40 kg/m2. A BMI < 18.5 kg/m2 was underweight. Incidences of VTE and bleeding complications were assessed. 
Duration January 1, 2013, to August 31, 2014
Outcome Measures

Primary: Incidence of confirmed VTE

Secondary: Incidence of major and minor bleeding

Baseline Characteristics   High-dose group (n= 751) Low-dose group (n= 584)
Body weight, kg Significantly greater in obese classes II and III -
BMI Significantly greater in obese classes II and III -
Major surgery - Higher in low-dose groups of obese classes II and III
Heart failure incidence Higher in high-dose group of obese class III -
Antiplatelet drug use Higher in high-dose group of obese class III -
Results   High-dose group (n= 751) Low-dose group (n= 584) p-value
Incidence of VTE 3% 1.5% 0.14
DVT occurrence 2.3% 1.4% 0.43
PE occurrence 0.9% 0.2% 0.08

Hemoglobin drop

≥ 2 g/dl (obese class II)

≥ 2 g/dl (obese class III)

 

30%

25

 

18%

12

 

<0.01

< 0.01

pRBC transfusion (obese class III) 11% 5% 0.01
Adverse Events Higher incidence of bleeding complications in high-dose group, particularly in obese classes II and III. Significant hemoglobin drop and increased pRBC transfusions in high-dose group. Minor bleeding (epistaxis) more common in high-dose group of obese class III.
Study Author Conclusions Higher doses of UFH were not associated with a decrease in VTE incidence but were associated with increased bleeding risk, especially in patients with BMI ≥ 40 kg/m2 receiving aspirin and high-dose UFH.
Critique The study's retrospective design and single-center setting limit generalizability. The lack of strict VTE screening criteria and potential for missed asymptomatic VTEs are limitations. The study did not reach the proposed sample size, which may affect the power to detect significant differences. A multicenter prospective study is recommended to confirm findings.
References:
[1] Joy M, Tharp E, Hartman H, et al. Safety and Efficacy of High-Dose Unfractionated Heparin for Prevention of Venous Thromboembolism in Overweight and Obese Patients. Pharmacotherapy. 2016;36(7):740-748. doi:10.1002/phar.1775

Efficacy and Safety of High-Dose Subcutaneous Unfractionated Heparin Prophylaxis for the Prevention of Venous Thromboembolism in Obese Hospitalized Patients
Design

Retrospective, single-center, cohort study

N= 2,378

Objective To compare rates of nosocomial VTE in obese patients treated with high-dose versus conventional-dose subcutaneous unfractionated heparin sodium (UFH) for thromboprophylaxis
Study Groups

High-dose heparin (n= 196)

Conventional-dose heparin (n= 2,182)

Inclusion Criteria Obese, adult, hospitalized patients admitted between April 2011 and April 2014 who received heparin 5,000 or 7,500 units subcutaneously every 8 hours for thromboprophylaxis
Exclusion Criteria Age <18 years, VTE on admission, bleeding on admission, receipt of therapeutic anticoagulation on admission or during hospitalization, receipt of enoxaparin during hospitalization, pregnancy or peripartum, imprisonment, paraplegia, major surgery, inpatient rehabilitation, history of heparin-induced thrombocytopenia confirmed with a positive Serotonin Release Assay
Methods Retrospective cohort study was conducted evaluating obese patients receiving high-dose (7,500 units subcutaneously q 8 h) versus conventional-dose (5,000 units subcutaneously q 8 h) heparin. Patients had to receive at least 3 consecutive doses of subcutaneous heparin. Nosocomial VTE and bleeding events were confirmed through manual chart review.
Duration April 2011 to April 2014
Outcome Measures

Primary: Rate of nosocomial VTE

Secondary: Bleeding events

Baseline Characteristics   Conventional-dose heparin (n = 2,182) High-dose heparin (n = 196) p-value
Mean age ± SD, years 58 ± 14.3 54 ± 13.3 <.0001
Female gender 1,349 (61.8) 92 (46.9) <.0001
LOS, days, median (range) 4 (1-188) 7 (1-136) <.0001
Chronic kidney disease 691 (31.7) 82 (41.8) .004
Heart failure 647 (29.7) 82 (41.8) .0004
ICU admission 377 (17.3) 85 (43.4) <.0001
Respiratory failure 294 (13.5) 95 (48.5) <.0001
Acute stroke 207 (9.5) 7 (3.6) .006
Results   Conventional-dose heparin (n = 2,182) High-dose heparin (n = 196) p-value
Nosocomial VTE, n (%) 5 (0.23) 2 (1.02) .05
DVT 3 2 -
PE 2 0 -
Bleeding, n (%) 2 (0.09) 0 (0) .67
Adverse Events No cases of major bleeding; minor bleeding occurred in 0% of patients in the high-dose group and 0.09% in the conventional-dose group
Study Author Conclusions This study failed to demonstrate a statistically significant reduction in the rate of nosocomial VTE in obese patients who received high-dose heparin thromboprophylaxis. Despite receiving a higher heparin dose, no increased risk of bleeding was observed in the high-dose group. Further investigation is needed to identify the optimal heparin dose for thromboprophylaxis in obese patients.
Critique The study provides valuable data on the use of high-dose heparin in obese patients, an area with limited evidence. However, the retrospective design and small sample size in the high-dose group may limit the conclusions. The use of ICD-9 codes for patient identification may have led to coding errors, and the heterogeneity in baseline characteristics between groups could have influenced the results.
References:
[1] Beall J, Woodruff A, Hempel C, Wovkulich M, Zammit K. Efficacy and Safety of High-Dose Subcutaneous Unfractionated Heparin Prophylaxis for the Prevention of Venous Thromboembolism in Obese Hospitalized Patients. Hosp Pharm. 2016;51(5):376-381. doi:10.1310/hpj5105-376
High dose subcutaneous unfractionated heparin for prevention of venous thromboembolism in overweight neurocritical care patients
Design

Single-center, retrospective, observational cohort study

N= 398

Objective To describe the incidence of bleeding and VTE occurrence associated with the use of heparin 7500 units Q8 h for patients who weigh over 100 kg and compare it with patients receiving the traditional dose of 5000 units Q8 h
Study Groups

High dose group (HDG) (n= 141)

Traditional dose group (TDG) (n= 257)

Inclusion Criteria Patients admitted to the neurosurgical intensive care unit from January 1, 2008 to December 31, 2012, weighing over 100 kg, and receiving heparin 5000 units Q8 h or 7500 units Q8 h for VTE prevention
Exclusion Criteria Patients who presented with VTE or treated with full dose anticoagulation medications on admission
Methods Retrospective analysis was conducted of patients receiving either 7500 units Q8 h or 5000 units Q8 h of subcutaneous UFH. In the middle of the 4 year mark, hospital protocol was adjsted to account for greater risk of VTEs in patients > 100 kg, prompting the protocol change from 5000 U Q8h to 7500 U Q8h. 
Duration January 1, 2008 to December 31, 2012
Outcome Measures

Primary: Occurrence of major hemorrhage

Secondary: Incidence of confirmed VTE, timing of initial dose of heparin and its association with VTE occurrence

Baseline Characteristics   Traditional dose (n= 257) High dose (n= 141) p-value
Age, mean (SD) 54 (16) 53 (15) 0.5
Body weight (kg), mean (SD) 116 (17) 123 (23) <0.01
Female, n (%) 75 (29) 49 (35) 0.26
GCS, (median, IQR) 14 (7–15) 12 (8–15) 0.27
Past medical history - VTE 5 (2) 8 (6) 0.05
Results   Traditional dose (n= 257) High dose (n= 141) p-value

Major bleeding events

Hgb drop 2 points in any 24 h

Hgb drop by 2 points from baseline

pRBC transfusion

 

28 (11%)

132 (51%)

52 (20%)

 

20 (14%)

81 (57%)

36 (26%)

 

0.33

0.24

0.22

Other bleeding events

Platelet drop by 50% from baseline

HIT

aPTT increased by X2 from baseline

Stool guaiac positive

 

17 (7%)

2 (0.8%)

9 (4%)

7 (3%)

 

11 (8)

0

5 (4%)

3 (2%)

 

0.55

0.54

0.59

0.72

Thromboembolism

DVT

PE

VTE

 

19 (7.4%)

6 (2.3%)

24 (9.3%)

 

6 (4.3%)

2 (1.4%)

8 (5.7%)

 

0.22

0.53

0.2

Concomitant antiplatelet medications

ASA

Clopidogrel

NSAIDs

 

41 (16%)

12 (5%)

41 (16%)

 

19 (14%)

30 (21%)

15 (11%)

 

0.56

<0.01

0.18

Heparin, units/kg/day

132 ± 15 187 ± 30 <0.01

Timing of initial dose of UFH, hours (IQR)

From admission 

From surgery

 

71 (36–156)

55 (29–160)

 

34 (24–53)

29 (23–47)

<0.01

< 0.01

Days on heparin, (IQR)

9 (2–26) 8 (1–19) 0.11

Length of stay in days (IQR)

15 (9–26) 11 (7–19) <0.01

Mortality, n (%)

16 (6) 13 (9) 0.55
Adverse Events No significant differences in major bleeding events between groups. Minor bleeding complications such as heparin induced thrombocytopenia, hematuria, epistaxis, or positive blood nasogastric aspirate were similar between groups.
Study Author Conclusions High dose subcutaneous UFH was not associated with an increased risk of bleeding, nor did it decrease the incidence of VTE in overweight patients. Early administration of heparin is crucial for VTE prevention.
Critique The study provides valuable insights into the safety of high dose UFH in overweight patients, but its retrospective design and single-center setting may limit generalizability. The lack of routine diagnostic screenings for VTE and reliance on clinical discretion could introduce bias. Larger, prospective studies are needed to confirm these findings.
References:
[1] Samuel S, Iluonakhamhe EK, Adair E, et al. High dose subcutaneous unfractionated heparin for prevention of venous thromboembolism in overweight neurocritical care patients. J Thromb Thrombolysis. 2015;40(3):302-307. doi:10.1007/s11239-015-1202-x