Abstract

In a prospective double-blind randomised study the efficacy and safety of a low mo-lecular Weight Heparin in Gynaecological Oncology: In a prospective double-blind randomised study the efficacy and safety of a low molecular weight heparin (LMWH) and unfractionated heparin (UFH) were compared in the use of perioperative prophylaxis for thrombosis in gynaecological patients undergoing major gynaecological cancer surgery. Three hundred and thirty patients were randomly allocated to the two prophylactic groups; 6 of these were dropouts of the study. Of the remaining 324 patients 160 received 3000 IU of low molecular weight heparin and 164 received subcutaneously 5000 IU unfractionated heparin 3 times a day (low dose heparin). Treatment was initiated 2 h preoperatively and continued for 7 days. The occurrence of deep vein thrombosis (DVT) was determind by impedance plethysmography (IPG) and phlebography. DVT was diagnosed in 10 of 160 patients (6.3%) treated with low molecular weight heparin and in 10 of 164 patients (6.1%) treated with low-dose heparin. DVT of proximal veins (including poplitea area) was detected in 4 patients of the LMWH group and in seven patients of the UFH group. During the observation (until 10 th postoperative day) 7 pulmonary embolism - 1 fatal and 6 unfatal - occurred in patients receiving prophylaxis with LMWH and 4 pulmonary embolisms (all unfatal) occurred in the UFH group. The incidence of wound haematoma (p = 0.01) and blood transfusions (p=0.0005) were statistically significantly increased in the UFH group. The results of this trial demon- strate that the low molecular weight heparin is as effective and safe as low dose heparin preventing DVT, but the incidences of bleeding complications were higher in the group with unfractionated heparin.

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