Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444470
Status:
COMPLETED
Last Update Posted:
2007-11-30
First Post:
2007-03-05
Brief Title:
Safety of Tranexamic Acid in Reducing Bleeding in Adults Undergoing Spinal Surgery
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Efficacy of Tranexamic Acid in Reducing Blood Loss in Adult Patients Having Major Spine Surgery
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None