Back to resultsEffect of Tranexamic Acid on Reducing Postoperative Blood Loss in Cervical Laminoplasty
Primary Purpose
Cervical Myelopathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Myelopathy focused on measuring perioperative blood loss, spinal surgery
Eligibility Criteria
Inclusion Criteria:
- Patients who were scheduled to undergo cervical laminoplasty from C3 to C6 for cervical multilevel compressive myelopathy with a narrow spinal canal for which nonoperative therapy had failed.
Exclusion Criteria:
- Patients with chronic renal failure, cirrhosis of the liver, serious cardiac disease, allergy to TXA, a history of thromboembolic disease, and bleeding disorders, as well as those who were currently receiving antiplatelet and/or anticoagulant drugs, were excluded from this study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
placebo, tranexamic acid
Arm Description
Outcomes
Primary Outcome Measures
perioperative blood loss
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01027546
Brief Title
Effect of Tranexamic Acid on Reducing Postoperative Blood Loss in Cervical Laminoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yodakubo Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose is to evaluate the efficacy of tranexamic acid in cervical laminoplasty; the surgical procedure used was identical in all cases.
Detailed Description
Tranexamic acid, an inhibitor of fibrinolysis, has proven to be effective in reducing perioperative blood loss in patients undergoing total hip and knee arthroplasty. However, limited numbers of well-controlled trials in spinal surgery have been conducted due to heterogeneity in the performed surgical procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Myelopathy
Keywords
perioperative blood loss, spinal surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo, tranexamic acid
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
Administer 15 mg/kg body weight of tranexamic Acid mixed in 100 mL saline intravenously over 15 min before the skin incision
Primary Outcome Measure Information:
Title
perioperative blood loss
Time Frame
during and after surgery
10. Eligibility
Sex
All
Eligibility Criteria
Inclusion Criteria:
Patients who were scheduled to undergo cervical laminoplasty from C3 to C6 for cervical multilevel compressive myelopathy with a narrow spinal canal for which nonoperative therapy had failed.
Exclusion Criteria:
Patients with chronic renal failure, cirrhosis of the liver, serious cardiac disease, allergy to TXA, a history of thromboembolic disease, and bleeding disorders, as well as those who were currently receiving antiplatelet and/or anticoagulant drugs, were excluded from this study.
12. IPD Sharing Statement
Learn more about this trial
Effect of Tranexamic Acid on Reducing Postoperative Blood Loss in Cervical Laminoplasty
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