What does the literature say about using heparin in flush fluid in lines vs saline flushes in the pediatric or neonatal population and what are the risks?

Comment by InpharmD Researcher

An updated Cochrane review suggests that there is no statistically significant difference between flushing central lines with heparin versus normal saline to maintain line patency or reducing bloodstream infections in the pediatric population based on the very low quality of evidence.

Background

An updated Cochrane review published in 2020 included four randomized controlled trials (RCTs) (N=255) which directly compared the clinical effects of intermittent flushing of normal saline versus heparin in preventing occlusion in long-term central venous catheters (CVCs) in infants and children aged up to 18 years of age. The results showed that the estimated relative risk (RR) for CVC occlusion per 1000 catheter days between the normal saline and heparin groups was 0.75 (95% confidence interval [CI] 0.10 to 5.51; 2 studies, 229 participants; P=0.78; I2 = 92%; very low certainty evidence). This suggested that there was no clear benefit in the outcome of CVC occlusion between flushing with heparin or normal saline. The estimated RR for CVC‐associated bloodstream infection was 1.48 (95% CI 0.24 to 9.37; 2 studies, 231 participants; P = 0.67; I2 = 45%; low‐certainty evidence). Again, the study did not find a clear difference between the use of saline to flush CVCs and the incidence of CVC-associated bloodstream infection. The duration of catheter placement was reported to be similar between the two groups in one study (203 participants; moderate‐certainty evidence), and not reported in the remaining studies. [1]

As noted in the results, not all included studies reported on all outcomes of interest; thus, the pooled analysis was only able to combine the results of the two studies (Cesaro 2009, Goosssens 2013). Of note, a non-inferiority trial by Goossens 2013 did include patients older than 1 year scheduled for insertion of CVC; however, the mean age was 57.9 years (standard deviation [SD] 14.8) and 54.9 years (SD 16.6) in the intervention arm (pulsatile flushing with 10 mL of normal saline) and the control arm (pulsatile flushing with 10 mL of normal saline, followed by 3 mL heparin (100 units/mL)), respectively. A subset of pediatric data (unpublished) was obtained by the study author to assess outcomes in 26 out of 28 children contributed data. However, not all variables were available, and there may be some systematic differences in the characteristics of children in this subset of data. In addition, the study was not powered to analyze this subset of data separately. [1]

Included studies instituted different protocols for the intervention and control arms, different concentrations of heparin, and different frequencies of flushes. Given the high risk of bias for non-blinding, a substantial degree of heterogeneity and inconsistency between the studies, and wide confidence intervals reported in the pooled analysis, the certainty of the evidence largely ranged from very low to low, at best. Based on these results, the authors concluded that there was not enough evidence to determine the effects of intermittent flushing with normal saline versus heparin to prevent occlusion in long‐term CVCs in infants and children. It remains unclear whether heparin is necessary to prevent occlusion, CVC‐associated bloodstream infection, or effects duration of catheter placement. [1]

Though not in the context of the neonate/pediatric population, another updated Cochrane review assessing the effectiveness and safety of intermittent locking of CVCs with heparin vs. normal saline to prevent occlusion in adults (11 studies; N=2,392) conveyed similar findings. The pooled analysis did show fewer occlusions with heparin than with normal saline (RR 0.70, 95% CI 0.51 to 0.95; P = 0.02; 1672 participants; 1025 catheters from 10 studies; I² = 14%), but it is based on a very low-quality of evidence given the differences in methodology, unclear allocation concealment, imprecision, and suspicion of publication bias. Furthermore, low‐quality evidence suggests that heparin may have little or no effect on the catheter patency. The study found no evidence of differences in safety (e.g., sepsis, mortality, or hemorrhage) and was not powered to detect rare adverse events such as heparin‐induced thrombocytopenia (HIT). Based on these findings, the authors concluded that there is uncertainty whether the intermittent locking with heparin results in fewer occlusions than intermittent locking with normal saline. [2]

The authors discussed potential risks associated with heparin use. The exposure of surgical patients to unfractionated heparin for longer than four days implies an overall risk of HIT of 2.6%, and an incidental administration of a heparin bolus through a catheter line intended for heparin locking may pose great harm, as well. From an economic stand of point, flushing with normal saline in place of heparin may yield a substantial saving in associated costs. A systematic review published in 1991 estimated yearly savings of 109 to 218 million dollars when peripheral venous lines were flushed with NS instead of heparin. [2], [3]

References:

[1] Bradford NK, Edwards RM, Chan RJ. Normal saline (0.9% sodium chloride) versus heparin intermittent flushing for the prevention of occlusion in long-term central venous catheters in infants and children. Cochrane Database Syst Rev. 2020;4(4):CD010996. doi: 10.1002/14651858.CD010996.pub3.
[2] López-Briz E, Ruiz Garcia V, Cabello JB, et al. Heparin versus 0.9% sodium chloride locking for prevention of occlusion in central venous catheters in adults. Cochrane Database Syst Rev. 2018;7(7):CD008462. doi: 10.1002/14651858.CD008462.pub3.
[3] Goode CJ, Titler M, Rakel B, et al. A meta‐analysis of effects of heparin flush and saline flush: quality and cost implications. Nursing Research 1991;40(6):324‐330.

Literature Review

A search of the published medical literature revealed 1 study investigating the researchable question:

What does the literature say about using heparin in flush fluid in lines vs saline flushes in the pediatric or neonatal population and what are the risks?

Please see Table 1 for your response.


 

Prospective, Randomized Trial of Two Different Modalities of Flushing Central Venous Catheters in Pediatric Patients with Cancer

Design

Phase III, randomized, open-label, prospective, controlled clinical trial

N=203

Objective

To ascertain if two different modalities of central venous catheter (CVC) flushing (standard flushing with heparin solution vs. experimental flushing with normal saline) were associated with significantly different CVC complication rates (primary aim) and/or different CVC survival rates (secondary aim)

Study Groups

Normal saline (n=101)

Heparin solution (n=102)

Inclusion Criteria

Pediatric patient (0 to 17 years of age, with malignant or non-malignant hematologic or oncologic disease with a Broviac-Hickman-type CVC (i.e., tunneled, partially inserted, open-ended, inserted for the purpose of chemotherapy of hematopoietic stem cell transplantation). 

Exclusion Criteria

Not explicitly stated. 

Methods

Eligible patients were randomized to receive standard flushing with heparin solution (3 mL of normal saline with 200 units heparin) twice weekly via a standard CVC cap or experimental flushing with normal saline at least weekly via a positive-pressure cap.

Duration

January 1, 2003 and January 31, 2005

Outcome Measures

Primary endpoint: Incidence of CVC complications (e.g., occlusion, dislocation of CVC, CVC-related infection, exit-site infection, thrombosis)

Secondary endpoint: CVC survival rates

Baseline Characteristics

 

Normal saline

(n=101)

Heparin solution

(n=102)

p-Value 

   

Median days at risk (range)

381 (11-1,072) 351 (4-1,073) p=0.5    

Age at CVC placement, years

< 5

≥ 5

 

39 (39%)

62 (61%)

 

41 (40%)

61 (60%)

 

p=0.8

 

 

 

 

Male

60 (59%) 60 (59%)

p=0.9

   

Underlying disease

Leukemia/lymphoma

Solid tumor/other

 

63 (62%)

38 (38%)

 

61 (60%)

41 (40%)

p=0.7 

 

 

 

Lumen number

Single

Double

 

51 (51%)

50 (49%) 

 

55 (54%)

47 (46%) 

p=0.6 

 

  

French diameter

< 7

≥ 7

 

48 (50%)

48 (50%)

 

48 (52%)

45 (48%)

 

p=0.8

 

 

 

Type of vessel accessed

Jugular

Subclavian

 

94 (94%)

6 (6%) 

 

90 (92%)

8 (8%) 

 

p=0.6 

 

 

 

 

Modality of insertion

Percutaenous

Surgical

 

76 (75%)

25 (25%)

 

67 (66%)

34 (34%)

p=0.2 

 

 

 

 

Results

Endpoint

Normal saline

(n=101)

Heparin solution

(n=102)

p-Value

CVC occlusion

83 (82.2%) 2.16 per 1,000 days 41 (40.2%) 1.11 per 1,000 days p=0.0002

Dislocation

18 (17.8%) 0.47 per 1,000 days 20 (19.6%) 0.54 per 1,000 days p=0.8

Bacteremia/fungemia

24 (23.8%)  0.62 per 1,000 days 9 (8.8%)  0.24 per 1,000 days p=0.01

Exit-site infection

10 (9.9%)  0.26 per 1,000 days 14 (13.7%) 0.38 per 1,000 days p=0.4

Thrombosis

1 (1.0%)  0.03 per 1,000 days 1 (1.0%) 0.03 per 1,000 days p=1.00

The median intervals from CVC placement to the first complication were 56 days (range, 2 to 414) and 42 days (1 to 345) for the experimental and standard arms, respectively (P=0.5).

After a median follow-up of 360 days (range, 4 to 1,073), CVC survival was similar: 77% (95% CI, 66% to 84%) for the experimental arm and 69% (95% CI, 53% to 80%) for the standard arm (P=0.7)

Adverse Events

Common Adverse Events: N/A

Serious Adverse Events: N/A

Percentage that Discontinued due to Adverse Events: N/A

Study Author Conclusions

An increased complication rate was found with normal saline flushing, but additional investigation is warranted to clarify whether it is related to saline use or to once-a-week flushing.

InpharmD Researcher Critique

A non-blinded single-center study conducted in Italy. Potential confounding of results due to outcomes being attributable to positive pressure cap or frequency between flushes rather than the flushing solution used. 

References:

Cesaro S, Tridello G, Cavaliere M, et al. Prospective, randomized trial of two different modalities of flushing central venous catheters in pediatric patients with cancer. J Clin Oncol. 2009;27(12):2059-2065. doi: 10.1200/JCO.2008.19.4860.