In a prospective, randomized study patients undergoing hysterectomy were treated either by the low molecular weight heparin Fragmin or by the combination of unfractionated sodium heparin + dihydroergotamin (HDHE). The dosage in the Fragmin group was 2× 2500 anti Xa-U on day 1 = day of surgery, from day 2-8: 1× 5000 anti Xa-U, in the HDHE-group from day 1-8: 2× 5000 IU heparin + 0.5 mg DHE. 99 patients were randomly allocated to prophylaxis with Fragmin, 101 to HDHE prophylaxis. 95 and 96 respectively were evaluated, the others excluded for different reasons. The 2 groups were comparable for general data and risk factors. Duration of surgery, intraoperative blood loss, transfusion rates and postoperative hemoglobin levels were identical. Blood volumes in subcutaneous and subfascial drainages were slightly but not significantly higher in the Fragmin group. In patients with an additional Marshall-Marchetti-operation, blood volumes in the drainages of the spatium retzii were significantly higher in patients on Fragmin. No differences were observed in the incidence of minor and major wound hematoma. Painful injections and sugillations at the injection sites were more frequently observed in the HDHE-group. The thermographic DeVeTherm test, which was carried out daily for diagnosis of DVT, gave positiv results (= temperature difference 1°C) on one day only in 14 patients of each group. The test was positive on 2 or more consecutive days in 4 patients on Fragmin and 2 patients on HDHE. Phlebography, which was carried out in the latter patients, gave a positive result in 1 patient of each group. Localization of DVT was mainly the lower limb. Plasma anti-Xa activity (S-2222) 4 hrs. after injection of 5000 anti-Xa IU Fragmin was 0.45 IU/ml being 10 fold higher than after HDHE. aPTT was slightly prolonged in both groups, thrombin time and thrombelastogramm gave even more pronounced changes in the Fragmin group. The present data indicate that Fragmin dosage should be further decreased to avoid bleeding complications.
Randomized study of subcutaneous low molecular weight heparin plus aspirin versus intravenous immunoglobulin in the treatment of recurrent fetal loss associated with antiphospholipid antibodies
