An open-label randomized controlled trial of low molecular weight heparin for the prevention of central venous line-related thrombotic complications in children: the PROTEKT trial.
OBJECTIVE
Central venous lines (CVLs) are major risk factors for venous thromboembolism (VTE) in children. The objective of PROTEKT was to determine if a low molecular weight heparin (reviparin-sodium) safely prevents CVL-related VTE.


METHODS
This multi-center, open-label study, with blinded central outcome adjudication, randomized patients with new CVLs to twice-daily reviparin-sodium or standard care. The efficacy outcome was based on an exit venogram at Day 30 (+14 days), or earlier in case of CVL removal, or confirmed symptomatic VTE. The safety outcomes were major bleeding and death. Due to slow and restricted patient accrual, PROTEKT was closed prematurely.


RESULTS
With reviparin-sodium, 14.1% (11:78) of patients had VTE compared to 12.5% (10:80) of control patients (odds ratio=1.15; 95% confidence interval 0.42, 3.23); 2P=0.82). One patient had a major bleed and there were two deaths, all three events occurring in the standard care group.


CONCLUSIONS
The use of reviparin-sodium for short-term prophylaxis of CVL-related VTE in children was safe but its efficacy remains unclear. Although underpowered, PROTEKT provided valuable information on event rates and predictors of CVL-related VTE.
Massicotte
Patricia
P
Department of Pediatrics, Division of Hematology/Oncology, Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto, Ontario, Canada M5G 1X8. patricia.massicotte@sickkids.ca
Julian
Jim A
JA
Gent
Michael
M
Shields
Karen
K
Marzinotto
Velma
V
Szechtman
Barbara
B
Chan
Anthony K
AK
Andrew
Maureen
M
D000293:Adolescent; D002405:Catheterization, Central Venous / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006495:Heparin, Low-Molecular-Weight / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D015912:Thrombolytic Therapy / Q000379:methods*; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*
D006495:Heparin, Low-Molecular-Weight; C094240:reviparin