defibrotide and Genital-Neoplasms--Female

Eighty-one patients were submitted to gynaecological malignancy surgery in a randomized study aimed at the evaluation of the efficacy of defibrotide (40 patients) and calcium heparin (41 patients) in perioperative prophylaxis. They were randomly allocated to defibrotide group (400 mg bid im starting one day before surgery and continuing until the 7th postoperative day) or calcium heparin group (5000 IU bid sc starting two hours before surgery and continuing likewise for 7 days). No cases of DVT diagnosed by means of a Doppler CW were observed in either treatment group. Laboratory parameters have shown similar modifications in the two treatment groups. Three cases of bleeding were observed in the calcium heparin group while no cases of bleeding were detected in the defibrotide group. The results obtained suggest that defibrotide is at least as effective as calcium heparin in perioperative DVT prevention and that the former drug has a possibly better tolerability profile, due to a decisively lower tendency to bleeding.

Topics: Aged; Calcium; Female; Fibrinolytic Agents; Genital Neoplasms, Female; Heparin; Humans; Middle Aged; Polydeoxyribonucleotides; Premedication; Thrombophlebitis

Deep venous thrombosis (DVT) can be a significant complication of the postoperative course in gynaecological surgery, because of traumatism and compression to which the vascular pelvic structures are subjected. A protocol was therefore designed to evaluate the effectiveness and tolerability of defibrotide, a new antithrombotic and profibrinolytic drug, compared with low-dose heparin. The study was conducted on 102 women, undergoing major gynaecological surgery for benign and malignant affections, randomly assigned to the following two treatment groups. A) defibrotide (400 mg i.v./i.m. b.i.d., starting the day before the surgery for 8 days); B) calcium heparin (5000 IU s.c. b.i.d., starting on the day of surgery, for/days). Clinical, haematological and instrumental (Doppler ultrasound) parameters were assessed and no major events were noted in either of the two treatment groups though in the calcium heparin group, 2 patients showed clinical signs of DVT (not confirmed by Doppler ultrasound) and no side effects were noticed, except for a cutaneous rash in one defibrotide patient and an episode of bleeding on the third postoperative day in a patient treated with calcium heparin. Defibrotide proved as effective as calcium heparin in the prevention of DVT in gynaecological surgery.

Topics: Clinical Trials as Topic; Drug Tolerance; Female; Fibrinolytic Agents; Genital Neoplasms, Female; Heparin; Humans; Polydeoxyribonucleotides; Postoperative Complications; Random Allocation; Thrombophlebitis; Time Factors; Ultrasonography