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

NCT01136590 | Completed Phase 4

• 2 other identifiers: TRANEX20092008-006938-94
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

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

Keywords

Spinal deformity correction; Surgical bleeding; Transfusion practice; Spinal Fusion; Antifibrinolytic Agents; Hemorrhage; Blood Transfusion

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period

  7 days postoperative period

Secondary Outcomes (2)

• Total blood loss: intraoperative and postoperative values

  48 hours postoperative

• Adverse events in the perioperative period, immediate postoperative period, and at mid-term

  up to 6 weeks after the procedure

Study Arms (2)

tranexamic acid

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid 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.

tranexamic acid

fisiologic serum 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)

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Hospital Vall d'Hebron: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital Universitari de Bellvitge: collaborator
• Hospital Universitario Getafe: collaborator

Study Sites (4)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08029, Spain

Location

Hospital Vall d'Hebron de Barcelona

Barcelona, Barcelona, 08035, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital de Getafe

Getafe, Madrid, Spain

Location

Related Publications (1)

• 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.

  PMID: 28203735 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Maria J Colomina, MD Ph

  Hospital Vall d'Hebron

  STUDY CHAIR

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 24, 2015

Record last verified: 2015-02

Locations

ES (4)