Safety of Tranexamic Acid in Reducing Bleeding in Adults Undergoing Spinal Surgery
|ClinicalTrials.gov Identifier: NCT00444470|
Recruitment Status : Completed
First Posted : March 7, 2007
Last Update Posted : November 30, 2007
|Condition or disease||Intervention/treatment||Phase|
|Spine Surgery||Drug: Tranexamic acid Drug: Placebo||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Efficacy of Tranexamic Acid in Reducing Blood Loss in Adult Patients Having Major Spine Surgery|
|Study Start Date :||February 2003|
|Study Completion Date :||May 2007|
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
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
- Total perioperative blood loss [ Time Frame: Measured intraoperatively and 24 hours postoperatively ]
- 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 ]
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444470
|Trillium Health Centre|
|Mississauga, Ontario, Canada, L5B 1B8|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Department of Anesthesia and Orthopedics; Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|Principal Investigator:||Jean Wong, MD, FRCPC||University Health Network, Toronto|
|Study Director:||Henry Ahn, MD, FRCPC||St. Michael's Hospital, Toronto|
|Study Director:||Robert McBroom, MD, FRCPC||Trillium Health Centre|