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Randomized Controlled Trial
. 2022 Nov-Dec;45(6):438-446.
doi: 10.1097/NCC.0000000000001053. Epub 2022 Feb 5.

Routine Catheter Lock Solutions in Pediatric Cancer Care: A Pilot Randomized Controlled Trial of Heparin vs Saline

Amanda J Ullman  1 , Rachel Edwards, Rick Walker, John Roy, Andrew Paton, Claire M Rickard, Marie Cooke, Natalie Bradford, Victoria Gibson, Paula Cattanach, Rebecca S Paterson, Mari Takashima, Joshua Byrnes, Samantha Keogh, Tricia Kleidon
Affiliations
Randomized Controlled Trial

Routine Catheter Lock Solutions in Pediatric Cancer Care: A Pilot Randomized Controlled Trial of Heparin vs Saline

Amanda J Ullman et al. Cancer Nurs. 2022 Nov-Dec.

Abstract

Background: Central venous access devices (CVADs) are integral to cancer care provision. Despite the high prevalence of CVAD complications in children with cancer, preventative strategies are understudied.

Objective: The aim of this study was to assess study feasibility, occlusive events, thrombolytic use, adverse events, and direct costs of catheter lock solutions.

Methods: A single-center, parallel-group, pilot randomized controlled trial was undertaken at a tertiary-referral pediatric hospital in Australia. Children 18 years or younger with an oncological or malignant hematological condition and a CVAD were eligible. Participants were 1:1 randomized to (1) normal or (2) heparinized (10-100 U/mL; CVAD-type dependent) saline lock solutions.

Results: Of 217 children assessed for eligibility, 61 were recruited and randomized to normal (n = 30; 3850 CVAD days) or heparinized (n = 31; 4036 CVAD days) saline. Eligibility (52%) and recruitment (54%) feasibility targets were not met. Protocol adherence was high (95% assessments), with no attrition. Parent/clinician satisfaction of interventions was high (median, 10/10 clinicians/parents). Complete CVAD occlusion occurred in heparin only (n = 2, 6.7% CVADs; incidence rate [IR], 0.49/1000 CVAD days [0.06-1.78]). Central venous access device partial occlusion was detected in 23.3% of CVADs in heparin (n = 7; IR, 2.73/1000 CVAD days [1.36-4.87]) and 13.8% of CVADs in normal saline (n = 4; IR, 2.59/1000 CVAD days [1.24-4.77]). Thrombolytic agents were used in 16.7% heparin (5 CVADs) and 3.5% normal saline (1 CVAD). Adverse events did not differ between groups.

Conclusion: Multisite randomized controlled trials examining CVAD locks are safe, but strategies and resources to increase recruitment and eligibility are required.

Implications for practice: Both routine CVAD lock solutions seem safe but may not prevent all forms of CVAD-associated harm.

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Conflict of interest statement

A.J.U. reports fellowships and grants by the National Health and Medical Research Council (NHMRC); grants by the Children’s Hospital Foundation, the Royal Brisbane and Women’s Hospital Foundation, Emergency Medicine Foundation, and the Australian College of Critical Care Nursing; and investigator-initiated research grants and speaker fees provided to her previous employer (Griffith University) from 3M, Cardinal Health, and Becton Dickinson. R.E. reports receiving the following on her behalf: grant funding from Children’s Hospital Foundation, ANZCHOG, and KCM. C.M.R. reports grants from the NHMRC, the Children’s Hospital Foundation, the Royal Brisbane and Women’s Hospital Foundation, the Australian College of Critical Care Nurses, and the Australian College of Nursing. C.M.R.’s previous employer (Griffith University) has received, on her behalf, investigator-initiated research grants from BD-Bard, Cardinal Health, and Eloquest, and consultancy payments for educational lectures/expert advice from 3M and BD-Bard. M.C. has received grant funding from Griffith University, Children’s Hospital Foundation, and NHMRC, and investigator-initiated research speaker fees provided to Griffith University by vascular access product manufacturers (Becton Dickinson), unrelated to this project. N.B. is supported by fellowship funding from the NHMRC. S.K. reports monies received from BD Medical by her employer Queensland University of Technology on her behalf for education consultancies unrelated to this study. T.K.’s employer has received the following on her behalf: grant funding from Children’s Hospital Foundation, Griffith University, NHMRC, and Emergency Medicine Foundation, and investigator-initiated research grants and speaker fees provided to Griffith University from vascular access product manufacturers 3M Medical, Access Scientific, BD-Bard, Cardinal Health, Medical Specialties Australia, Smiths Medical, and Vygon. All other authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
CONSORT flow diagram of study participants.
Figure 2
Figure 2
Kaplan-Meier comparing heparin with normal saline.
See this image and copyright information in PMC

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