[Prevention of thrombosis with fraxiparin 0.3 after ambulatory surgery].
AIMS AND METHODOLOGY: Between September 1993 and January 1994, a post surveillance study involving 113 physicians in private practise was carried out to investigate the efficacy and safety of the low-molecular-weight heparin. Fraxiparin 0.3. The aim of the study was to obtain information about the usual prescription of approved drugs. In this case, the efficacy based on the incidence of thromboembolic events (deep vein thrombosis in the leg, pulmonary embolism) and tolerability on the basis of the recording of undesired adverse reactions were to be investigated in a large group of patients undergoing ambulatory operations. RESULTS: Participants in the study comprised 1028 men and women aged between 13 and 93 years who, for the most part, underwent operations on the lower limbs with subsequent immobilization. As a preventive measure against thromboembolic complications, all patients received a daily subcutaneous injection of fraxiparin 0.3. The duration of the prophylaxis was determined by the physician on an individual basis and was 9 days on average. During the course of the drug monitoring, 12 cases of deep vein thrombosis of the leg (1.2%) and 2 pulmonary embolism (0.2%) occurred. Eight of the 14 patients with thromboembolic complications also had additional risk factors. In ten of these 14 cases, patients were younger than 40 years (average age of the overall group: 42.8 years). A noteworthy observation was the fact that in four cases, the venous thromboses in the leg occurred only after the last injection of heparin. The results confirm that preventive Fraxiparin 0.3 provides reliable protection against thromboembolic disease in patients undergoing ambulatory surgery. The low rate of undesired side-effects (1.3%) underscores the high level of tolerability of this drug.