An open-label comparison of the efficacy and safety of certoparin versus unfractionated heparin for the prevention of thromboembolic complications in acutely ill medical patients: CERTAIN.

OBJECTIVE: Guidelines recommend low-dose unfractionated heparin (UFH) and low-molecular-weight heparin for the prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients. We report the findings of an open-label, active-controlled, multicenter study in acutely ill medical patients comparing certoparin and UFH. RESEARCH DESIGN AND METHODS: Open-label, active-controlled, multicenter study. Patients received certoparin 3000 IU daily or UFH 7500 IU twice daily. MAIN OUTCOME MEASURES: The primary endpoint was a composite of symptomatic or asymptomatic proximal or distal deep vein thrombosis, symptomatic pulmonary embolism, or VTE-related death.
RESULTS: 172 patients were randomized to UFH and 163 to certoparin for 8.5 ± 2.1 days. The incidence of the primary endpoint was 18.0% in patients receiving UFH and 10.7% with certoparin [absolute difference -7.3; 95% confidence interval (CI) -16.9 to 2.3; p = 0.1353]. The incidence during follow-up was 2.6% in the UFH and 2.0% in the certoparin group (absolute difference -0.6; 95%CI -4.0 to 2.8; p = 0.7150). Major bleeding events occurred in three patients with UFH and one patient with certoparin.
CONCLUSIONS: In acutely ill medical patients of at least 40 years of age, thromboprophylaxis with certoparin 3000 IU daily is effective and safe in comparison with 7500 IU twice daily UFH.

RCT Entities:   Population Interventions Outcomes