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

NCT ID: NCT01027546

Last Updated: 2009-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cervical Myelopathy

Keywords

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perioperative blood loss, spinal surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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placebo, tranexamic acid

Group Type PLACEBO_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

Administer 15 mg/kg body weight of tranexamic Acid mixed in 100 mL saline intravenously over 15 min before the skin incision

Interventions

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Tranexamic Acid

Administer 15 mg/kg body weight of tranexamic Acid mixed in 100 mL saline intravenously over 15 min before the skin incision

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yodakubo Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yodakubo hospital

Other Identifiers

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YODA-0001

Identifier Type: -

Identifier Source: org_study_id