Trial | NCT00444470  Report issue

Title

Safety of Tranexamic Acid in Reducing Bleeding in Adults Undergoing Spinal Surgery
Efficacy of Tranexamic Acid in Reducing Blood Loss in Adult Patients Having Major Spine Surgery

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    151
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.
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:

Tranexamic acid reduces the estimated perioperative blood loss in adult patients undergoing elective spinal fusion.
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.
Study Started
Feb 28
2003
Study Completion
May 31
2007
Last Update
Nov 30
2007
Estimate

Drug 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.

  • Other names: Tranexamic acid is known by the brand name Cyclokapron

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.

  • Other names: Normal Saline is used as placebo

A Active Comparator

Active drug being tested in this study is Tranexamic Acid

B Placebo Comparator

Normal saline was used as the Placebo

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
No Results Posted