Enoxaparin in the prevention of deep venous thrombosis after major surgery: multicentric study. The Italian Study Group.

DVT is a very frequent complication of general surgery. Heparin and, more recently, LMWHs can successfully prevent post surgical thromboembolism. One thousand one hundred and twenty-two patients (533 males and 589 females; mean age 62.2 +/- 11.4 yrs) were enrolled in a multicentre controlled study, to evaluate the efficacy and safety of enoxaparin in comparison to calcium heparin in the prevention of deep venous thrombosis (DVT) following general surgery. Patients assigned to the enoxaparin and the calcium heparin groups received 1 daily dose of 20 mg (2000 I.U.) and 2 daily doses of 0.2 ml (5000 I.U.), respectively starting 2 hours before the operation. Both drugs were given by subcutaneous route. A Doppler or Duplex Scan diagnosis of DVT was made in 3 (0.5%) patients in the enoxaparin group (2 cases during treatment and 1 patient at the end of treatment) and in 6 (1.1%) patients in the calcium heparin group (5 cases during treatment and 1, bilateral, after the end of treatment). Pulmonary embolism (PE) was ascertained by angiography in 1 patient (0.18%) in the enoxaparin group and in 2 patients (0.36%) in the calcium heparin one. Hemorrhagic complications occurred in 29 patients (5.2%) in the enoxaparin group and in 34 (6.1%) in the calcium heparin group. Haematomas located in the injection site were reported in 16.1% and 25.3% in the enoxaparin and calcium heparin groups respectively (p = 0.0001). Local pain in the injection site at the 5th day of treatment was reported in 8.4% and 16.6% in the enoxaparin and calcium heparin groups respectively (p = 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes