Randomized trial of subcutaneous low-molecular-weight heparin CY 216 (Fraxiparine) compared with intravenous unfractionated heparin in the curative treatment of submassive pulmonary embolism. A dose-ranging study.
1992; Lippincott Williams & Wilkins; Volume: 85; Issue: 4 Linguagem: Inglês
10.1161/01.cir.85.4.1380
ISSN1524-4539
AutoresC Théry, Gérald Simonneau, Guy Meyer, O. Hélénon, Françoise Bridey, C. Armagnac, Pascal d’Azemar, J.-P. Coquart,
Tópico(s)Blood Coagulation and Thrombosis Mechanisms
ResumoBACKGROUND We compared the efficacy and safety of different dosages of a low-molecular-weight heparin, CY 216 D (Fraxiparine), in the treatment of submassive pulmonary embolism with unfractionated heparin in a prospective, randomized, dose-finding study. METHODS AND RESULTS The primary outcome was the evolution of pulmonary vascular obstruction. We enrolled 101 patients. Four patient groups were formed: standard heparin by continuous intravenous infusion (group 1) and Fraxiparine subcutaneously 400, 600, and 900 anti-Xa Institute Choay units/kg, respectively (groups 2, 3, and 4). Inclusions were stopped prematurely in groups 3 and 4 because of the incidence of major bleedings. At day 8, the improvement of the pulmonary vascular obstruction and the major bleedings were similar in groups 1 and 2. CONCLUSIONS The Fraxiparine dosage of 400 anti-Xa Institute Choay units/kg is as effective and safe as unfractionated heparin in the treatment of submassive pulmonary embolism.
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