Can KCentra be used in patients with HIT history?

Comment by InpharmD Researcher

Four-factor prothrombin complex concentrate (4F-PCC) is generally not recommended in patients with a history of heparin-induced thrombocytopenia (HIT) because it contains heparin and is specifically contraindicated in individuals with known HIT. HIT is a prothrombotic immune-mediated reaction, and major guidelines emphasize strict avoidance of heparin exposure, particularly within the first three months after diagnosis when recurrence risk is highest. In addition, observational data with 4F-PCC demonstrate a measurable thromboembolic risk, and HIT has been identified as a significant risk factor for thrombosis following administration. Therefore, in patients with a history of HIT, especially recent or active HIT, alternative non-heparin reversal strategies should be considered and individualized based on bleeding urgency and thrombotic risk.

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Background

The 2018 American Society of Hematology (ASH) guidelines by provide evidence-based recommendations for the diagnosis and management of heparin-induced thrombocytopenia (HIT), a prothrombotic immune-mediated adverse drug reaction caused by antibodies directed against platelet factor 4 (PF4)–heparin complexes. The guidelines outline management strategies across the five phases of HIT, including acute, subacute (A and B), and remote HIT. In patients with acute HIT, the panel recommends discontinuation of heparin and initiation of a non-heparin anticoagulant. For patients with remote HIT who require venous thromboembolism (VTE) treatment or prophylaxis, the panel recommends administration of a non-heparin anticoagulant rather than unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH). In procedural settings such as cardiovascular surgery, intraoperative heparin may be considered in patients with subacute HIT B or remote HIT, but exposure should be limited to the intraoperative period and avoided before and after surgery. The guideline emphasizes that the risk of HIT recurrence with heparin re-exposure is greatest within the first 3 months after diagnosis, and management decisions should account for the phase of HIT and the balance of thrombotic and bleeding risks. [1]

The 2012 edition ACCP guidelines provide comprehensive, evidence-based recommendations for the prevention, diagnosis, and management of heparin-induced thrombocytopenia (HIT), a prothrombotic immune-mediated adverse reaction caused by antibodies against platelet factor 4 (PF4)-heparin complexes. The guideline outlines the clinical presentation of HIT, which most commonly occurs 5-10 days after heparin exposure and is associated with a significant risk of venous and arterial thrombosis. The authors emphasize the importance of clinical probability assessment, recommending use of a validated scoring system such as the 4Ts score to estimate pretest probability prior to laboratory testing. Laboratory evaluation should include immunoassays for HIT antibodies, with functional assays such as the serotonin release assay used for confirmation when indicated. For management, the guideline recommends immediate discontinuation of all heparin products in patients with suspected or confirmed HIT. In patients with HIT complicated by thrombosis (HITT), treatment with a nonheparin anticoagulant, such as argatroban, lepirudin, or danaparoid, is recommended over continued heparin therapy or initiation of vitamin K antagonists (VKAs). VKAs should not be initiated until platelet counts recover and must overlap with a nonheparin anticoagulant for at least 5 days. The guideline also addresses monitoring strategies, suggesting platelet count monitoring in patients receiving heparin who are at higher risk of HIT. Overall, the authors conclude that early recognition, appropriate diagnostic testing, and prompt initiation of alternative anticoagulation are critical to reducing thrombotic complications and improving outcomes in patients with HIT. [2]

The 2008 ACCP guidelines provide evidence-based recommendations for the recognition, treatment, and prevention of heparin-induced thrombocytopenia (HIT), an antibody-mediated adverse reaction to heparin that is strongly associated with venous and arterial thrombosis. HIT is described as a clinicopathologic syndrome requiring both compatible clinical findings and laboratory confirmation of platelet factor 4 (PF4)-dependent antibodies. The guidelines recommend that clinicians suspect HIT in patients receiving heparin who experience a platelet count fall greater than 50% and/or develop a new thrombotic event between days 5 and 14 of heparin initiation, even if heparin has already been discontinued. For management, immediate discontinuation of all heparin products is recommended in patients with strongly suspected or confirmed HIT, regardless of whether thrombosis is present. The panel recommends treatment with a nonheparin anticoagulant, such as danaparoid, lepirudin, argatroban, fondaparinux, or bivalirudin, over continued use of unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), or initiation/continuation of vitamin K antagonists (VKAs). . VKAs should not be started until the platelet count has substantially recovered (typically ≥150 × 10⁹/L), should be initiated at low maintenance doses, and must overlap with a nonheparin anticoagulant for at least five days. . In patients already receiving VKAs at the time of HIT diagnosis, administration of vitamin K is recommended. . Overall, the guideline emphasizes that early recognition, appropriate diagnostic evaluation, and prompt initiation of alternative anticoagulation are critical to reducing thrombotic complications and mortality associated with HIT. [3]

A 2021 review evaluated the role of four factor prothrombin complex concentrate (4F PCC) in the management of critical bleeding across several clinical settings, including cardiac surgery, trauma induced coagulopathy, liver failure, and reversal of oral factor Xa inhibitors. The review highlights that although 4F PCC is FDA approved for vitamin K antagonist reversal, its use has expanded into multiple off label indications. Across these settings, available randomized and observational studies suggest that 4F PCC can reduce plasma transfusion requirements, improve INR values, and achieve effective hemostasis in a majority of patients. However, the authors emphasize ongoing concerns regarding thromboembolic risk. In cardiac surgery and trauma populations, thrombotic events have been reported, though rates vary across studies and are difficult to interpret due to heterogeneity and observational designs. In patients with liver disease, while INR correction is frequently achieved, this does not necessarily correlate with improved hemostasis, and thrombotic complications such as portal vein thrombosis have been described. For factor Xa inhibitor associated intracranial hemorrhage, retrospective data demonstrate high rates of effective hemostasis, but thromboembolic events remain a potential complication. Overall, the authors conclude that while 4F PCC appears effective for rapid coagulation factor replacement and hemostatic support, its prothrombotic potential must be carefully considered, and additional prospective data are needed to better define safety and optimal use in high risk patient populations. [4]

A 2016 study evaluated the safety and effectiveness of four factor prothrombin complex concentrate (4F PCC) in a real world setting for patients with life threatening bleeding or requiring emergent surgery. . The study included 93 adult patients, of whom 67.7% received 4F PCC for bleeding and 32.3% for urgent surgical intervention. The primary outcome was the incidence of confirmed thromboembolism within 14 days of administration. Thromboembolic events occurred in 11.8% of patients, with a median time to event of 5 days. Significant risk factors associated with thromboembolism included heparin induced thrombocytopenia (HIT) (P= 0.01) and major surgery within 14 days (P= 0.02). Among the 63 patients who received 4F PCC for warfarin reversal, 71.4% achieved an INR <1.5 at the first measurement and 87.3% achieved this target within 24 hours. However, 25.5% of those who initially corrected experienced INR rebound, and more than half of these patients had not received concomitant vitamin K within 4 hours of administration. Hemostatic effectiveness was achieved in 73.6% of evaluable bleeding cases. The authors concluded that while 4F PCC is effective for rapid warfarin reversal and hemostasis, it is associated with a notable thromboembolic risk, and patient specific thrombotic risk factors, particularly HIT, should be carefully considered prior to administration. [5]

References: [1] Cuker A, Arepally GM, Chong BH, et al. American Society of Hematology 2018 guidelines for management of venous thromboembolism: heparin-induced thrombocytopenia. Blood Adv. 2018;2(22):3360-3392. doi:10.1182/bloodadvances.2018024489
[2] Linkins LA, Dans AL, Moores LK, et al. Treatment and prevention of heparin-induced thrombocytopenia: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e495S-e530S. doi:10.1378/chest.11-2303
[3] Warkentin TE, Greinacher A, Koster A, Lincoff AM. Treatment and prevention of heparin-induced thrombocytopenia: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 Suppl):340S-380S. doi:10.1378/chest.08-0677
[4] Tanaka KA, Shettar S, Vandyck K, Shea SM, Abuelkasem E. Roles of Four-Factor Prothrombin Complex Concentrate in the Management of Critical Bleeding. Transfus Med Rev. 2021;35(4):96-103. doi:10.1016/j.tmrv.2021.06.007
[5] Sin JH, Berger K, Lesch CA. Four-factor prothrombin complex concentrate for life-threatening bleeds or emergent surgery: A retrospective evaluation. J Crit Care. 2016;36:166-172. doi:10.1016/j.jcrc.2016.06.024
Relevant Prescribing Information

Contraindications: Patients with known heparin-induced thrombocytopenia (HIT). KCENTRA contains heparin [6]

References: [6] Kcentra (prothrombin, coagulation factor vii human). Prescribing information. CSL Behring GmbH. May 2023
Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

Can KCentra be used in patients with HIT history?

Level of evidence

C - Multiple studies with limitations or conflicting results  Read more→



Please see Tables 1-2 for your response.


 

 

Four-factor prothrombin complex concentrate for life-threatening bleeds or emergent surgery: A retrospective evaluation
Design Retrospective study N= 93
Objective To evaluate the safety and effectiveness of 4F-PCC in a real-world setting based on an institutional protocol that does not have strict exclusion criteria
Study Groups

Bleeding (n= 63)

Surgery (n= 30)

Inclusion Criteria All patients 18 years of age and older who received at least one dose of 4F-PCC between March 1, 2014 and December 31, 2014
Exclusion Criteria No exclusion criteria applied
Methods Retrospective analysis of adult patients who received 4F-PCC. Primary outcome was confirmed thromboembolism within 14 days after 4F-PCC administration. Secondary outcomes included INR correction to <1.5 at first draw and incidence of INR rebound for patients undergoing reversal of warfarin and hemostatic effectiveness for patients experiencing a bleed
Duration March 1, 2014 to December 31, 2014
Outcome Measures

Primary: Confirmed thromboembolism within 14 days

Secondary: INR correction to <1.5 at first draw, incidence of INR rebound, hemostatic effectiveness for bleeds

Baseline Characteristics   All patients (N = 93) Bleeding (n = 63) Surgery (n = 30)
Age, y 67 (56 to 79) 68 (59 to 81) 61 (52 to 75)
Sex, male 63 (67.7%) 39 (61.9%) 24 (80%)
Weight, kg 78.6 (69 to 95.6) 78.6 (67.1 to 100.4) 79 (71.2 to 88.8)
Dose of 4F-PCC, IU 2,000 (1788 to 2,500) 2,000 (1,500 to 2,500) 2,000 (1,938 to 2,425)
Baseline INR for warfarin patients 3 (2.1 to 3.8) 3.1 (2.3 to 4.4) 2.2 (1.7 to 3.5)
Results   All patients (N = 93)    
Thromboembolism within 14 days 11 (11.8%)    
INR correction at first draw 45/63 (71.4%)    
INR correction within 24 hours 55/63 (87.3%)    
INR rebound 14/55 (25.5%)    
Adverse Events 4F-PCC was associated with a notable thromboembolic risk. Significant risk factors included heparin-induced thrombocytopenia and major surgery within 14 days. 
Study Author Conclusions 4F-PCC was associated with a notable thromboembolic risk. All patient-specific risk factors should be considered prior to administration. 4F-PCC remains a useful agent for warfarin reversal. Lack of concomitant vitamin K may contribute to INR rebound. 
Critique The study provides valuable real-world data on the use of 4F-PCC without strict exclusion criteria, highlighting its effectiveness and associated thromboembolic risks. However, the retrospective design limits the ability to establish causality, and the lack of a control group may affect the interpretation of the results. Additionally, the study's findings may not be generalizable to all patient populations due to the specific institutional protocol used. 

 

References:
[1] [1] Sin JH, Berger K, Lesch CA. Four-factor prothrombin complex concentrate for life-threatening bleeds or emergent surgery: A retrospective evaluation. J Crit Care. 2016;36:166-172. doi:10.1016/j.jcrc.2016.06.024

 

On The Use Of Prothrombin Complex Concentrate In Patients With Coagulopathy Requiring Tooth Extraction

Design

Case series 

Case presentation 1

A 38-year-old woman with dilated cardiomyopathy supported by a left ventricular assist system (LVAS) was receiving aspirin and warfarin with a target PT-INR of 4.5 (range 4.0–5.0). Her INR prior to intervention was 4.94. Because of HIT, unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) were contraindicated. She received 500 units of PCC intravenously 30 minutes before tooth extraction. Fifteen minutes later, PT-INR decreased to 1.43. Tooth extraction and curettage were performed with local hemostatic measures. Warfarin was resumed the evening after surgery. PT-INR returned to ≥4.0 by postoperative day 2. Postoperative bleeding was mostly absent, although a transient hematoma occurred when PT-INR rose to 6.0–7.5, requiring fresh frozen plasma. No thrombotic events were reported. 

Case presentation 2

A 27-year-old man with dilated cardiomyopathy supported by LVAS was also receiving aspirin and warfarin with a target PT-INR of 4.5 (range 4.0–5.0). His INR was 4.80 prior to the procedure. Due to HIT, heparin bridging was not an option. He received 500 units of PCC intravenously 30 minutes before surgical extraction. Fifteen minutes later, PT-INR decreased to 1.50. The procedure was completed with adequate local hemostasis. Warfarin was resumed the same evening. PT-INR returned to therapeutic range by postoperative day 2. No postoperative bleeding or thrombotic complications were observed. 

Study Author Conclusions

The authors concluded that short-term warfarin reversal using PCC allowed successful dental extraction in patients with HIT who were receiving high-level anticoagulation therapy (PT-INR ≥ 4.5). PCC provided rapid INR reduction, enabled adequate hemostasis, and avoided the use of heparin bridging, which is contraindicated in HIT. They suggested PCC is a useful strategy for managing procedural anticoagulation in HIT patients requiring temporary warfarin reversal. 
References:
[1] [1] Morimoto Y, Niwa H, Nakatani T. On the use of prothrombin complex concentrate in patients with coagulopathy requiring tooth extraction. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010;110(6):e7-e10. doi:10.1016/j.tripleo.2010.08.014