Dihydroergotamine-heparin prophylaxis of postoperative deep vein thrombosis. A multicenter trial. The Multicenter Trial Committee
In a large, prospective, multicenter investigation of the prophylaxis of
deep vein thrombosis (DVT) in patients undergoing elective abdominal,
pelvic, and thoracic surgery, 880 patients were randomized into five
treatment groups: those receiving (1) dihydroergotamine mesylate, 0.5 mg,
plus heparin sodium, 5,000 IU; (2) dihydroergotamine mesylate, 0.5 mg, plus
heparin sodium, 2,500 IU; (3) heparin sodium, 5,000 IU alone; (4)
dihydroergotamine mesylate, 0.5 mg alone; or (5) placebo. Treatment was
initiated preoperatively and continued twice daily for five to seven days.
Daily radiofibrinogen uptake tests revealed the following DVT rates:
Dihydroergotamine mesylate, 0.5 mg, plus heparin sodium, 5,000 IU, 9.4%;
dihydroergotamine mesylate, 0.5 mg, plus heparin sodium, 2,500 IU, 16.8%;
heparin sodium, 5,000 IU alone, 16.8%; dihydroergotamine mesylate, 0.5 mg
alone, 19.4%; and placebo, 24.4%. Dihydroergotamine mesylate, 0.5 mg, plus
heparin sodium, 5,000 IU, was significantly superior to all other
treatments. Adverse drug experiences did not differ significantly between
groups and consisted primarily of postoperative bleeding (2% to 3%),
injection site hematoma (6% to 12%), and wound hematoma (1% to 3%).
