Preventing postoperative deep venous thrombosis in gynecological surgery with defibrotide.

This was an open, fully randomized clinical study designed to compare the effectiveness and tolerability of defibrotide and calcium heparin as prophylactic agents for preventing postoperative DVT of the lower limbs in patients scheduled for gynecological surgery for nonmalignant disease (100 cases) or for tumoral pathology (60 cases). Defibrotide was administered by intramuscular injection in doses of 400 mg b.i.d., starting one day before surgery and continuing for seven postoperative days (n = 80); calcium heparin was given by subcutaneous injection in doses of 5000 IU t.i.d., starting two hours before surgery and continuing likewise for seven days (n = 80). DVT was to be diagnosed by computerized impedance plethysmography. Not a single case of DVT occurred in either treatment group; nor were there any significant differences in the magnitude of surgical or postoperative bleeding or in pertinent laboratory test returns. The Authors conclude that defibrotide can be used to advantage instead of calcium heparin as a measure for preventing DVT of the lower limbs in patients undergoing major surgery for gynecologic disorders including malignancy.

RCT Entities:   Population Interventions Outcomes