Overview

Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery

Status:
Completed

Trial end date:
2014-05-01

Target enrollment:

Participant gender:

Summary

Current evidence regarding the efficacy and safety of perioperative administration of tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal surgery. OBJECTIVES: To evaluate the effectiveness of tranexamic acid for decreasing transfusion requirements and bleeding in this patient population. To evaluate the safety of this antifibrinolytic agent in the intraoperative and mid-term postoperative period. METHODS: Multicenter, randomized, double-blind, placebo-controlled clinical trial with parallel groups. The main outcome measure is intraoperative and postoperative transfusion requirements; blood loss and safety will also be evaluated. Previous results in other types of surgery suggest that tranexamic acid reduces transfusion requirements and blood loss. Hence, the hypothesis of this study is that tranexamic acid will significantly reduce blood loss in comparison to a placebo in major spine surgery.

Phase:

Phase 4

Details

Lead Sponsor:

Hospital Universitari Vall d'Hebron Research Institute

Collaborators:

Hospital Clinic of Barcelona
Hospital Universitari de Bellvitge
Hospital Universitario Getafe
Hospital Vall d'Hebron

Treatments:

Tranexamic Acid