• Plos One · Jan 2018

    Randomized Controlled Trial Multicenter Study

    Low-molecular-weight heparin venous thromboprophylaxis in critically ill patients with renal dysfunction: A subgroup analysis of the PROTECT trial.

    • Menaka Pai, Adhikari Neill K J NKJ Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada. , Marlies Ostermann, Diane Heels-Ansdell, James D Douketis, Yoanna Skrobik, Ismael Qushmaq, Maureen Meade, Gordon Guyatt, William Geerts, Michael W Walsh, Mark A Crowther, Jan O Friedrich, Lisa Burry, Rinaldo Bellomo, Nilton Brandão da Silva, Costa Filho Rubens R Pró Cardíaco Hospital, PROCEP, Rio de Janeiro, Brazil., Michael J Cox, Suzana Alves Silva, Deborah J Cook, and PROTECT (Prophylaxis for Thromboembolism in Critical Care Trial) Investigators.
    • Department of Medicine, McMaster University, Hamilton, Canada.
    • Plos One. 2018 Jan 1; 13 (6): e0198285.

    IntroductionThere is concern about excessive bleeding when low-molecular-weight heparins (LMWHs) are used for venous thromboembolism (VTE) prophylaxis in renal dysfunction. Our objective was to evaluate whether LMWH VTE prophylaxis was safe and effective in critically ill patients with renal dysfunction by conducting a subgroup analysis of PROTECT, a randomized blinded trial.MethodsWe studied intensive care unit (ICU) patients with pre-ICU dialysis-dependent end-stage renal disease (ESRD; pre-specified subgroup; n = 118), or severe renal dysfunction at ICU admission (defined as ESRD or non-dialysis dependent with creatinine clearance [CrCl] <30 ml/min; post hoc subgroup; n = 590). We compared dalteparin, 5000 IU daily, with unfractionated heparin (UFH), 5000 IU twice daily, and considered outcomes of proximal leg deep vein thrombosis (DVT); pulmonary embolism (PE); any VTE; and major bleeding. Adjusted hazard ratios [HR] were calculated using Cox regression.ResultsIn patients with ESRD, there was no significant difference in DVT (8.3% vs. 5.2%, p = 0.76), any VTE (10.0% vs. 6.9%; p = 0.39) or major bleeding (5.0% vs. 8.6%; p = 0.32) between UFH and dalteparin. In patients with severe renal dysfunction, there was no significant difference in any VTE (10.0% vs. 6.4%; p = 0.07) or major bleeding (8.9% vs. 11.0%; p = 0.66) but an increase in DVT with dalteparin (7.6% vs. 3.7%; p = 0.04). Interaction p-values for comparisons of HRs (ESRD versus not) were non-significant.ConclusionsIn critically ill patients with ESRD, or severe renal dysfunction, there was no significant difference in any VTE or major bleeding between UFH and dalteparin. Patients with severe renal dysfunction who received dalteparin had more proximal DVTs than those on UFH; this finding did not hold in patients with ESRD alone.

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