Effect of Tranexamic Acid on Reducing Postoperative Blood Loss in Cervical Laminoplasty
Sponsor
Yodakubo Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01027546
Collaborator
(none)
40
1
16
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Study Start Date
:
Jan 1, 2007
Actual Primary Completion Date
:
May 1, 2008
Actual Study Completion Date
:
May 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: placebo, tranexamic acid
|
Drug: Tranexamic Acid
Administer 15 mg/kg body weight of tranexamic Acid mixed in 100 mL saline intravenously over 15 min before the skin incision
|
Outcome Measures
Primary Outcome Measures
- perioperative blood loss [during and after surgery]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Yodakubo Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01027546
Other Study ID Numbers:
- YODA-0001
First Posted:
Dec 8, 2009
Last Update Posted:
Dec 8, 2009
Last Verified:
May 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: