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

NCT00444470 | Completed Phase 3 DMC

• 1 other identifier: P.S.I. Grant No. 02-69
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 3

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.

Conditions

Spine Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total perioperative blood loss

  Measured intraoperatively and 24 hours postoperatively

Secondary Outcomes (2)

• Incidence of autologous or allogeneic blood transfusion, including red blood cells and coagulation components, i.e., FFP and platelets

  Administered during entire hospitalization

• Other secondary outcomes will include hemoglobin concentration, fatigue and functional recovery, and duration of hospital stay.

  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.

Study Arms (2)

A

ACTIVE COMPARATOR

Active drug being tested in this study is Tranexamic Acid

Drug: Tranexamic acid

B

PLACEBO COMPARATOR

Normal saline was used as the Placebo

Drug: Placebo

Interventions

Tranexamic acid 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.

Also known as: Tranexamic acid is known by the brand name Cyclokapron

A

Placebo 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.

Also known as: Normal Saline is used as placebo

B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (3)

Trillium Health Centre

Mississauga, Ontario, L5B 1B8, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Department of Anesthesia and Orthopedics; Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

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

• Jean Wong, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Henry Ahn, MD, FRCPC

  Unity Health Toronto

  STUDY DIRECTOR

• Robert McBroom, MD, FRCPC

  Trillium Health Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 7, 2007
• Study Start: February 1, 2003
• Study Completion: May 1, 2007
• Last Updated: November 30, 2007

Record last verified: 2007-11

Locations

CA (3)