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

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00444470
First received: March 5, 2007
Last updated: November 29, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Spine Surgery
Drug: Tranexamic acid
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Tranexamic Acid in Reducing Blood Loss in Adult Patients Having Major Spine Surgery

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Total perioperative blood loss [ Time Frame: Measured intraoperatively and 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of autologous or allogeneic blood transfusion, including red blood cells and coagulation components, i.e., FFP and platelets [ Time Frame: Administered during entire hospitalization ] [ Designated as safety issue: No ]
  • Other secondary outcomes will include hemoglobin concentration, fatigue and functional recovery, and duration of hospital stay. [ Time Frame: Hemoglobin concentration will be measured pre-operatively, intraoperatively and on post-operative days 1-3. Fatigue questionnaire will be completed at the pre-operative admission, post-operative days 3 and 7, and after discharge at 6 weeks. ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: February 2003
Study Completion Date: May 2007
Arms Assigned Interventions
Active Comparator: A
Active drug being tested in this study is Tranexamic Acid
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 Name: Tranexamic acid is known by the brand name Cyclokapron
Placebo Comparator: B
Normal saline was used as the Placebo
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 Name: Normal Saline is used as placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444470

Locations
Canada, Ontario
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 1B8
Department of Anesthesia and Orthopedics; Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Jean Wong, MD, FRCPC Toronto Western Hospital - University Health Network
Study Director: Henry Ahn, MD, FRCPC St. Michael's Hospital, Toronto
Study Director: Robert McBroom, MD, FRCPC Trillium Health Centre
  More Information

No publications provided

Responsible Party: Jean Wong, MD, FRCPC, Department of Anesthesia, Toronto Western Hospital
ClinicalTrials.gov Identifier: NCT00444470     History of Changes
Other Study ID Numbers: P.S.I. Grant No. 02-69
Study First Received: March 5, 2007
Last Updated: November 29, 2007
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
tranexamic acid
safety
efficacy
spine surgery
spinal fusion and decompression
adult
perioperative
blood loss
bleeding
blood transfusion

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014