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

NCT ID: NCT01136590

Last Updated: 2015-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

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

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)

Group Type: PLACEBO_COMPARATOR

fisiologic serum

Intervention Type: DRUG

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)

Interventions

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.

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Vall d'Hebron

OTHER

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: collaborator

Hospital Universitario Getafe

OTHER

Sponsor Role: collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria J Colomina, MD Ph

Role: STUDY_CHAIR

Hospital Vall d'Hebron

Misericordia Basora, MD Ph

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Maylin Koo, MD Ph

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Javier Pizones, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Getafe.

Locations

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Hospital Vall d'Hebron de Barcelona

Barcelona, Barcelona, Spain

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital de Getafe

Getafe, Madrid, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 28203735 (View on PubMed)

Other Identifiers

2008-006938-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TRANEX2009

Identifier Type: -

Identifier Source: org_study_id