Effect of Tranexamic Acid on Reducing Postoperative Blood Loss in Cervical Laminoplasty

Cervical Myelopathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027546
• Other study ID #: YODA-0001
• Status: Completed
• Phase: N/A
• First received: December 7, 2009
• Last updated: December 7, 2009
• Start date: January 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Yodakubo Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose is to evaluate the efficacy of tranexamic acid in cervical laminoplasty; the surgical procedure used was identical in all cases.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Myelopathy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yodakubo Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perioperative blood loss		during and after surgery	No