Low-molecular-weight heparinoid orgaran is more effective than aspirin in the prevention of venous thromboembolism after surgery for hip fracture.

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 125I-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.

Acute and delayed emesis after cisplatin-based regimen: description and prevention.

Lorazepam, dexamethasone and high-dose metoclopramide were given to 54 patients to prevent emesis induced by cisplatin (50-120 mg/m2) on day 1, while prochlorperazine and dexamethasone were administered on days 2 and 3 for control of delayed emesis. Nausea and emesis were recorded from day 1 to day 8. This combination was well tolerated. Prevention on day 1 was complete for 72% of patients and satisfactory (less than or equal to 2 emeses on day 1) in 85%. From days 2 to 8, no emesis, less than or equal to 2 and greater than 2 episodes occurred in 70, 11 and 19%, respectively. Overall control (days 1-8) was complete in 55.5% and satisfactory (less than or equal to 2 emeses on day 1 and/or less than or equal to 2 emeses from days 2 to 8) in 74%. Delayed emesis started on days 2-5. Mean duration was 2.6 days. Delayed nausea or emesis were more frequent when emesis occurred on day 1. Based on data previously reported and on these observations, better ways to prevent delayed events are discussed. Further trials must record systematically delayed side effects.