Comparative efficacy and safety of rivaroxaban and subcutaneous enoxaparin in perevention of venous thrombo embolic events after spinal instrumentation

In this study, hemorrhagic events caused by taking rivaroxaban and enoxaparin will be investigated.

A controlled clinical trial, with parallel groups, double blind, randomized, For randomization the rand function of Excel software was used.

This study will be performed in educational and medical centers of Al-Zahra, Isfahan, Iran.

Inclusion criteria: all patients who undergo spinal device placement; patient consent to participate in the study; the patient's high risk of venous thromboembolism. Exclusion criteria: use of anticoagulant in the last 3 months; urine test with purpura-positive blood or cutaneous hematoma of active bleeding or high risk of bleeding; presence of active cancer as an underlying disease or cancer treated in the last 6 months; hospitalization in home and inactivity for more than 3 days; body mass index more than 35; history of PTE and DVT and smoking more than 20 cigarettes a day.

The intervention group received 15 mg rivaroxaban tablets and the control group received 1 mg / kg / day subcutaneous enoxaparin ampoule.

Occurrence of venous thromboembolism

Random function of Excel software based on patient file number will be used for randomization. Patients undergoing spinal surgery were included in the Excel program based on the file number and were divided into case and control groups based on the random button. There were two groups of 35 people in total. By entering the file number in Excel program, then the random number is selected from the data analysis command. This study has 2 groups that can be numbered from 1 to 2, respectively. We also want 200 people in each group. As a result, sequences 1 to 2 should be repeated 100 times each time. It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 100 for repeating the sequence. In this way, 200 pieces will be produced.