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Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty

NCT01651806 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-12-13

Study results available
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Summary

Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This includes having a greater impact on decreasing blood loss without increasing the occurrence of adverse thromboembolic events in patients undergoing primary, elective total knee arthroplasty.

Secondary - TA will decrease blood loss more effectively in women than in men undergoing this procedure.

Conditions

Interventions

DRUG

Tranexamic Acid standard dose

Uniform 1 gram dosing

DRUG

Females Tranexamic Acid weighted dose

Weighted dose--20mg/kg of the drug will be given

DRUG

Females receiving a uniform dose of TA

Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.

DRUG

Males Weighted Dose TA

Weighted dose--20mg/kg of the drug will be given

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Mark Belkin, BS · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01651806 on ClinicalTrials.gov