Prophylaxis of thromboembolic disease with RO-11 (ROVI), during abdominal surgery. EMRO1 (Grupo Fstudio Multicintrico RO-11)

Abstract

Background/aims: We carried out a prospective, multicenter, double-blind, controlled and randomized trial, in two groups of patients (n = 100 each) with a low/moderate risk of Deep vein thrombosis (DVT), who underwent elective abdominal surgery. The aim of the study was to evaluate the efficacy and safety of RO-11 at a daily s.c. dose of 2,500 anti-FXa IU, compared with s.c. 5,000 IU of calcium unfractionated heparin (UH).

Material and methods: The endpoints for efficacy were the reduction of the frequency of DVT and Pulmonary embolism (PE). Safety was assessed by means of major and minor bleeding complications, allergy and thrombocytopenia < or = 50,000/mm3. RO-11 is a low molecular mass heparin (LMMH) (3,600 Da). RO-11 at a s.c. dose of 2,500 anti F-Xa IU combined with placebo experimental group (EG), was compared to 5,000 anti F-Xa IU of s.c. UH 12 hourly control group (CG), for 7 days.

Results: There were no cases of DVT, PE or death in any group. The requirement of transfusion, re-operation because of bleeding, and the frequency of wound hematoma were higher in the CG. The size of the wound hematoma was similar but tended to be larger in the CG. The number and size of hematoma at the injection site were higher in the CG. The mean anti F-Xa levels in the EG were similar throughout the treatment. One patient (EG) showed a moderate thrombocytopenia without thrombosis or bleeding.

Conclusion: RO-11 at a single s.c. dose of 2,500 anti F-Xa IU is as efficient as, and safer than, UH in the prevention of thrombosis or related to abdominal surgery.