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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Blood Transfusion; Spinal Fusion; Antifibrinolytic Agents
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: fisiologic serum

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron de Barcelona
  • Barcelona, Spain, 08029
    • Hospital Clinic de Barcelona
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain
      • Hospital de Bellvitge
  • Madrid
    • Getafe, Madrid, Spain
      • Hospital de Getafe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients ≥18 years old of both sexes
• scheduled for complex spine surgery
• ASA I-III
• weighing more than 30 kg
• body mass index <30 kg/m2
• operated on in the participating hospitals
• major spinal surgery
• signed an informed consent form to be included in the study

Exclusion Criteria:

• a history of allergy or hypersensitivity to the agent used
• receiving medication that can interfere with coagulation (acetylsalicylic acid, oral anticoagulants, or antiplatelet agents)
• a history of frequent bleeding
• plasma creatinine values >1.5 mg/dL in the baseline analysis
• platelet count less than 150,000/mm3 in the follow-up analysis
• abnormal prothrombin time (INR >1.5) or partial thromboplastin time (INR >1.5)
• a history of a thromboembolic episode before surgery
• family history of thromboembolism
• lack of consent to participate in the study
• infectious disease, tumor or trauma of the spine as the reason for surgery
• scheduled for surgery with an anterior and posterior surgical approach, whether sequential or on the same day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tranexamic acid; tranexamic acid will be administered as a bolus (10-mg/kg dose ) 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: 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.
Placebo Comparator: placebo; 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)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period	7 days postoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total blood loss: intraoperative and postoperative values	Intraoperative blood loss is evaluated by measuring the volume of suction aspirate and weighing the swabs with a precision digital scale. Postoperative blood loss is determined by recording the volume of blood collected through the suction drains at 24 and 48 hours.	48 hours postoperative
Adverse events in the perioperative period, immediate postoperative period, and at mid-term	Adverse events in the perioperative period, immediate postoperative period, and at mid-term (up to 6 weeks after the procedure) will be recorded, with special emphasis on follow-up of thrombotic events and clinically suspected deep venous thrombosis, renal function, and visual abnormalities reported by the patient	up to 6 weeks after the procedure

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Hospital Clinic of Barcelona; Hospital Universitari de Bellvitge; Hospital Vall d'Hebron; Hospital Universitario Getafe
• Investigators: Study Chair: Maria J Colomina, MD Ph, Hospital Vall d'Hebron; Principal Investigator: Misericordia Basora, MD Ph, Hospital Clinic of Barcelona; Principal Investigator: Maylin Koo, MD Ph, Hospital Universitari de Bellvitge; Principal Investigator: Javier Pizones, MD, Hospital de Getafe.

Publications and helpful links

General Publications

• Colomina MJ, Koo M, Basora M, Pizones J, Mora L, Bago J. Intraoperative tranexamic acid use in major spine surgery in adults: a multicentre, randomized, placebo-controlled trialdagger. Br J Anaesth. 2017 Mar 1;118(3):380-390. doi: 10.1093/bja/aew434.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 2, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (Estimate): June 3, 2010

Study Record Updates

• Last Update Posted (Estimate): February 24, 2015
• Last Update Submitted That Met QC Criteria: February 23, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Blood Transfusion; Hemorrhage; Spinal Fusion; Antifibrinolytic Agents; Surgical bleeding; Spinal deformity correction; Transfusion practice
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TRANEX2009; 2008-006938-94 (EudraCT Number)