Safety of Tranexamic Acid in Reducing Bleeding in Adults Undergoing Spinal Surgery

NCT ID: NCT00444470

Last Updated: 2007-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2007-05-31

Brief Summary

Spinal fusion surgery can be associated with significant blood loss requiring allogeneic blood transfusion. Tranexamic acid is a synthetic amino acid with antifibrinolytic action that has been shown to reduce perioperative blood loss in patients undergoing cardiopulmonary bypass for cardiac bypass surgery, knee replacement and liver transplantation surgeries. The efficacy of antifibrinolytics for reduction of blood loss in major spine surgery has not been well studied in adult patients. The objective of this study is to determine the efficacy of tranexamic acid in reducing perioperative blood loss and blood transfusion in adults undergoing elective spinal fusion in a larger, multi-centered, randomized, double-blinded, placebo controlled trial.

Detailed Description

Spinal fusion can be associated with significant blood loss requiring allogeneic blood transfusion (ABT). Ongoing concerns about the costs, risks, and availability of allogeneic blood have prompted the implementation of multiple techniques (preoperative erythropoetin, autologous pre-donation, intra-operative blood salvage, and induced hypotension) to reduce the necessity of ABT. However, 28% of patients undergoing spinal fusion at the Toronto Western Hospital still receive ABT. Also, none of these modalities (with the exception of induced hypotension) actually reduce the amount of blood shed from the surgical wound; thus the severity of anemia is largely unaffected. Consequently, many of these patients can suffer from adverse effects of anemia postoperatively as well as potential complications from blood transfusions.

The underlying assumption of the proposed study is that excessive fibrinolysis occurs during spinal fusion surgery. This can result in increased and recurrent blood loss, which can exacerbate the significant amount of bleeding already associated with major spine surgery.

Tranexamic acid - an antifibrinolytic drug blocks the dissolution of hemostatic fibrin, which stabilizes fibrin structures, and thus may decrease blood loss secondary to increased fibrinolysis.

This research proposal will test the following hypotheses:

1. Tranexamic acid reduces the estimated perioperative blood loss in adult patients undergoing elective spinal fusion.

2. Tranexamic acid reduces the need for blood transfusion in adult patients undergoing elective spinal fusion.

This multi-centered trial will be valuable for establishing the efficacy and safety of tranexamic acid for reducing blood loss and allogeneic blood transfusion in adults having elective spinal fusion. Tranexamic acid is easy to administer, is relatively inexpensive, and has not been associated with significant adverse effects. If it is shown to be efficacious, it can be incorporated into routine clinical practice as part of the multi-modal perioperative blood conservation techniques currently used to reduce perioperative blood loss, transfusion and the risk of allogeneic blood transfusion.

Conditions

Spine Surgery

Keywords

tranexamic acid; safety; efficacy; spine surgery; spinal fusion and decompression; adult; perioperative; blood loss; bleeding; blood transfusion

Study Design

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

Study Groups

A

Active drug being tested in this study is Tranexamic Acid

Group Type: ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type: DRUG

Eligible patients who have consented to be in the study and have been randomised to be in Arm "A" will receive 10 mg/kg of tranexamic acid, and then a continuous infusion of 1 mg/kg/hr of tranexamic acid.

B

Normal saline was used as the Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Eligible patients who have consented to be in the study and have been randomised to be in Arm "B" will receive 10 mg/kg of placebo followed by a continuous infusion of 1 mg/kg/hr of placebo.

Interventions

Tranexamic acid

Eligible patients who have consented to be in the study and have been randomised to be in Arm "A" will receive 10 mg/kg of tranexamic acid, and then a continuous infusion of 1 mg/kg/hr of tranexamic acid.

Intervention Type: DRUG

Placebo

Eligible patients who have consented to be in the study and have been randomised to be in Arm "B" will receive 10 mg/kg of placebo followed by a continuous infusion of 1 mg/kg/hr of placebo.

Intervention Type: DRUG

Other Intervention Names

Tranexamic acid is known by the brand name Cyclokapron; Normal Saline is used as placebo

Eligibility Criteria

Inclusion Criteria

• All adult patients (greater than 18 years old) undergoing elective posterior thoracic/lumbar instrumented spinal fusion.

Exclusion Criteria

• Participation in another clinical trial
• Allergy to TA
• Spinal tumor/Intradural pathology
• Ankylosing spondylitis
• Acquired disturbances of color vision
• Preoperative anemia (Hb <110 in females, Hb <120 in males)
• Refusal of blood products (Jehovah's witnesses)
• Preoperative use of anticoagulant therapy - coumadin, heparin within 5 days of surgery
• Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment
• Hematological disease (thromboembolic events, hemoglobinopathy, coagulopathy or hemolytic disease)
• Preoperative platelet count <150,000/cubic mm, INR>1.4, prolonged PTT
• Significant co-morbidities: Previous MI ; severe ischemic heart disease (NYHA Class III, IV) ; severe pulmonary disease ; chronic renal failure ; hepatic failure ; uncontrolled hypertension
• Pregnancy or lactation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Department of Anesthesia, Toronto Western Hospital

Principal Investigators

Jean Wong, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Henry Ahn, MD, FRCPC

Role: STUDY_DIRECTOR

Unity Health Toronto

Robert McBroom, MD, FRCPC

Role: STUDY_DIRECTOR

Trillium Health Centre

Locations

Trillium Health Centre

Mississauga, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Department of Anesthesia and Orthopedics; Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

P.S.I. Grant No. 02-69

Identifier Type: -

Identifier Source: org_study_id