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

This study has been completed.
Sponsor:
Information provided by:
Yodakubo Hospital
ClinicalTrials.gov Identifier:
NCT01027546
First received: December 7, 2009
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Takahiro Tsutsumimoto, Yodakubo hospital
ClinicalTrials.gov 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:
Bone Marrow Diseases
Spinal Cord Diseases
Postoperative Hemorrhage
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Hemorrhage
Pathologic Processes
Postoperative Complications
 Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013