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

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.

Conditions

• Spinal Fusion
• Antifibrinolytic Agents
• Hemorrhage
• Blood Transfusion

Interventions

DRUG

Tranexamic Acid

A 10-mg/kg dose of tranexamic acid will be administered as a bolus or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery.

DRUG

fisiologic serum

The placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery)

Sponsors & Collaborators

• Hospital Vall d'Hebron

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hospital Universitari de Bellvitge

  collaborator OTHER

• Hospital Universitario Getafe

  collaborator OTHER

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Principal Investigators

• Maria J Colomina, MD Ph · Hospital Vall d'Hebron

• Misericordia Basora, MD Ph · Hospital Clinic of Barcelona

• Maylin Koo, MD Ph · Hospital Universitari de Bellvitge

• Javier Pizones, MD · Hospital de Getafe.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2014-05-31

Completion

2014-05-31

Countries

• Spain

Study Locations