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

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ClinicalTrials.gov Identifier: NCT01027546
Recruitment Status : Completed
First Posted : December 8, 2009
Last Update Posted : December 8, 2009
Information provided by:
Yodakubo Hospital

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
Cervical Myelopathy Drug: Tranexamic Acid

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : January 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. perioperative blood loss [ Time Frame: during and after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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.

Responsible Party: Takahiro Tsutsumimoto, Yodakubo hospital
ClinicalTrials.gov Identifier: NCT01027546     History of Changes
Other Study ID Numbers: YODA-0001
First Posted: December 8, 2009    Key Record Dates
Last Update Posted: December 8, 2009
Last Verified: May 2008

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

Additional relevant MeSH terms:
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action