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

This study has been completed.
Information provided by:
Yodakubo Hospital Identifier:
First received: December 7, 2009
Last updated: NA
Last verified: May 2008
History: No changes posted

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

Condition Intervention
Cervical Myelopathy
Drug: Tranexamic Acid

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

Resource links provided by NLM:

Further study details as provided by Yodakubo Hospital:

Primary Outcome Measures:
  • perioperative blood loss [ Time Frame: during and after surgery ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Genders Eligible for Study:   Both

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.
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  More Information

No publications provided

Responsible Party: Takahiro Tsutsumimoto, Yodakubo hospital Identifier: NCT01027546     History of Changes
Other Study ID Numbers: YODA-0001
Study First Received: December 7, 2009
Last Updated: December 7, 2009
Health Authority: Japan: Institutional Review Board

Keywords provided by Yodakubo Hospital:
perioperative blood loss, spinal surgery

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2014