An open-label randomized controlled trial of low molecular weight heparin for the prevention of central venous line-related thrombotic complications in XXXX : the PROTEKT trial.

@entity1 @entity548 @entity1372 @entity1211 @entity204
OBJECTIVE(S): Central venous lines (CVLs) are major risk factors for @entity1211 ( @entity1211 ) in @entity1 . The objective of PROTEKT was to determine if a low molecular weight heparin (reviparin- @entity1372 ) safely prevents CVL-related @entity1211 . STUDY DESIGN: This multi-center, open-label study, with blinded central outcome adjudication, randomized @entity1 with new CVLs to twice-daily reviparin- @entity1372 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 @entity1211 . The safety outcomes were @entity548 and @entity204 . Due to slow and restricted @entity1 accrual, PROTEKT was closed prematurely. RESULTS: With reviparin- @entity1372 , 14.1% (11:78) of @entity1 had @entity1211 compared to 12.5% (10:80) of control @entity1 (odds ratio=1.15; 95% confidence interval 0.42, 3.23); 2P=0.82). One @entity1 had a @entity548 and there were two deaths, all three events occurring in the standard care group. CONCLUSIONS: The use of reviparin- @entity1372 for short-term prophylaxis of CVL-related @entity1211 in @entity1 was safe but its efficacy remains unclear. Although underpowered, PROTEKT provided valuable information on event rates and predictors of CVL-related @entity1211 .
