[Comparative study of defibrotide and calcium heparin in the prevention of postoperative deep venous thrombosis. A randomized multicenter study].
The efficacy and tolerability of defibrotide (800 mg/i.v.) and calcium heparin (15,000 UI/s.c.) in the prophylaxis of post-surgical deep venous thrombosis (DVT) and pulmonary embolism (PE) were compared in a multicentre trial involving 60 Italian surgical institutions (general surgery, obstetrics and gynecology, urology). Total enrollment was 2,250 patients (defibrotide: 1.194; calcium heparin 1.056). According to the protocol, the clinical suspicion of DVT and/or PE led to in-depth diagnostic evaluations (DVT: Doppler ultrasound velocimetry; PE: chest X-rays; ECG, pulmonary scintigraphic scanning). The incidence of post-surgical DVT was similar in the two groups (defibrotide: 8 patients; calcium heparin: 10 patients). A trend towards a lower incidence of DVT in the defibrotide group no PE; calcium heparin: 4 cases (chi 2 = 4.530, p less than 0.05). The local and systemic tolerability of both treatment was excellent. This trial, carried out in routine surgical practice, establishes the profibrinolytic approach to DVT prophylaxis as a sound and effective alternative to the traditional interference with the coagulation cascade.
D000704:Analysis of Variance; D002986:Clinical Trials as Topic; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006493:Heparin / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011089:Polydeoxyribonucleotides / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control*; D011655:Pulmonary Embolism / Q000517:prevention & control; D011897:Random Allocation; D013924:Thrombophlebitis / Q000517:prevention & control*
D005343:Fibrinolytic Agents; D011089:Polydeoxyribonucleotides; C006871:calcium heparin; C036901:defibrotide; D006493:Heparin
Studio di confronto defibrotide-eparina calcica nella profilassi della trombosi venosa profonda post-operatoria. Studio multicentrico randomizzato.