Low-molecular-weight heparinoid orgaran is more effective than aspirin in the prevention of venous thromboembolism after surgery for hip fracture
| Autor: | Mark Levine, Jacques R. Leclerc, Peter Powers, Jeffrey S. Ginsberg, William Geerts, Michael Gent, Alexander G.G. Turpie, Jean Neemeh, Richard M. Jay, Jack Hirsh |
|---|---|
| Rok vydání: | 1996 |
| Předmět: |
Adult
Male medicine.medical_specialty medicine.drug_class Injections Subcutaneous Venography Administration Oral Dermatan Sulfate law.invention Postoperative Complications Randomized controlled trial Double-Blind Method law Physiology (medical) Thromboembolism medicine Humans Vein Aged Aged 80 and over Aspirin Hip fracture medicine.diagnostic_test business.industry Hip Fractures Anticoagulant Chondroitin Sulfates Anticoagulants Middle Aged medicine.disease Thrombosis Pulmonary embolism Surgery medicine.anatomical_structure Anesthesia Female Heparitin Sulfate Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | Circulation. 93(1) |
| ISSN: | 0009-7322 |
| Popis: | Background The study objective was to determine the relative efficacy and safety of a low-molecular-weight heparinoid (Orgaran) compared with aspirin for the prevention of postoperative venous thromboembolism in patients undergoing surgery for fractured hips. A double-blind, randomized, controlled trial was used to study 251 consecutive eligible and consenting patients undergoing surgery for hip fracture in seven participating hospitals. Methods and Results Patients received either fixed-dose Orgaran by subcutaneous injection every 12 hours in a dose of 750 anti–Factor Xa units or aspirin 100 mg orally twice daily; both regimens were started 12 to 24 hours after surgery and continued for 14 days or until discharge, if sooner. All patients had postoperative 125 I-fibrinogen leg scanning and impedance plethysmography. If the results of one or both tests were positive, then venography was performed. Otherwise, venography was done at day 14, or sooner if the patient was ready for discharge. Pulmonary embolism in symptomatic patients was diagnosed on the basis of a high probability perfusion/ventilation lung scan, a positive angiogram, or a clinically significant embolism detected at autopsy. Evaluable venograms were obtained in 90 of the 125 patients randomly assigned to receive Orgaran and in 87 of the 126 patients assigned to receive aspirin. Venous thromboembolism was detected in 25 (27.8%) patients in the Orgaran group and in 39 (44.3%) patients in the aspirin group. Thus, there was a relative risk reduction of 37% with Orgaran ( P =.028; 95% confidence interval, 3.7% to 59.7%). Six (6.8%) of 88 patients in the Orgaran group and 12 (14.3%) of 84 patients in the aspirin group developed proximal deep vein thrombosis or pulmonary embolism, a relative risk reduction of 52% with Orgaran ( P =.137; 95% confidence interval, −30.7% to 84.6%). Hemorrhagic complications occurred in 2 (1.6%) patients given Orgaran and 8 (6.4%) patients given aspirin ( P =.10). There was one major bleed in the Orgaran group compared with four in the aspirin group. Conclusions This study demonstrates that Orgaran is significantly more efficacious than aspirin in preventing postoperative venous thromboembolism in patients undergoing surgery for fractured hips, with no evidence of any increase in hemorrhagic complications. |
| Databáze: | OpenAIRE |
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