Spine SurgeryPhase 3NCT00444470
Safety of Tranexamic Acid in Reducing Bleeding in Adults Undergoing Spinal Surgery
A Phase 3 study testing Tranexamic acid in people with Spine Surgery, run by University Health Network, Toronto at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spine Surgery
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 3 sitesCanada
- Study dates
- Feb 2003to May 2007
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (greater than 18 years old) undergoing elective posterior thoracic/lumbar instrumented spinal fusion.
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Department of Anesthesia and Orthopedics; Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: Efficacy of Tranexamic Acid in Reducing Blood Loss in Adult Patients Having Major Spine Surgery
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.
Read the 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:
- 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.
- Conditions
- Spine Surgery
- Being tested
- Tranexamic acid, Placebo
- Keywords
- tranexamic acid, safety, efficacy, spine surgery, spinal fusion and decompression, adult, perioperative, blood loss, bleeding, blood transfusion
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Tranexamic acid is known by the brand name Cyclokapron
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.
PlaceboDrug
Also called Normal Saline is used as 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.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Active drug being tested in this study is Tranexamic Acid Receives: Drug: Tranexamic acid |
| B | Placebo comparator | Normal saline was used as the Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total perioperative blood loss
Measured: 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
Measured: Administered during entire hospitalization
Other secondary outcomes will include hemoglobin concentration, fatigue and functional recovery, and duration of hospital stay.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startFeb 2003
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Jean Wong, MD, FRCPC, Principal investigator, University Health Network, TorontoHenry Ahn, MD, FRCPC, Study director, Unity Health TorontoRobert McBroom, MD, FRCPC, Study director, Trillium Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444470
- Sponsor's protocol ID
- P.S.I. Grant No. 02-69
- Status last verified
- Nov 2007
- First submitted
- 5 Mar 2007
- Last updated
- 30 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes