Low molecular weight heparin plus dihydroergotamine for prophylaxis of postoperative deep vein thrombosis.
In a prospective, double-blind investigation of the prophylaxis of deep vein thrombosis (DVT) in patients undergoing elective major abdominal surgery, 269 patients were randomized into two groups. One hundred and thirty-two patients received a fixed combination of heparin sodium 5000 units plus dihydroergotamine mesylate 0.5 mg (H/DHE) twice a day and 137 patients received a fixed combination of low molecular weight heparin 1500 units plus dihydroergotamine mesylate 0.5 mg (LMWH/DHE) once a day as well as one injection of placebo per day. Treatment was initiated 2 h pre-operatively in both groups and continued for 7-10 days. The frequency of DVT determined by the 125I-labelled fibrinogen uptake test and phlebography was 10.3 per cent in patients receiving H/DHE and 10.4 per cent in those receiving LMWH/DHE. DVT of the femoral vein was detected in four patients of the H/DHE group and in none of the LMWH/DHE group. Intra- and postoperative blood loss did not differ significantly between both groups. Also no difference in the development of wound haematoma and injection site haematoma was found. While intra-operative volume substitution was comparable in both groups, significantly more patients under H/DHE prophylaxis received volume substitution during the postoperative phase. These results show that once-daily prophylaxis with the combination of low molecular weight heparin and dihydroergotamine is equally as effective and as safe as the twice-daily regimen using a combination of unfractionated heparin and dihydroergotamine in patients undergoing elective, major abdominal surgery. The advantages of the once-daily regimen of LMWH/DHE include greater patient acceptance, less nursing time and greater cost effectiveness, provided the new combination can be sold at a cost which maintains this advantage.
D000005:Abdomen / Q000601:surgery; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D004087:Dihydroergotamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008970:Molecular Weight; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D013924:Thrombophlebitis / Q000517:prevention & control*
D004087:Dihydroergotamine; D006493:Heparin