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Tranexamic Acid in Revision Total Joint Arthroplasty

NCT02877381 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2021-04-22

No results posted yet for this study

Summary

To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA) \[single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral repeated dosing\] to minimize post-operative blood loss and transfusion requirements following revision total knee arthroplasty (RTKA).

Conditions

  • Revision Total Knee Arthroplasty
  • Revision Total Hip Arthroplasty
  • Acute Blood Loss Anemia

Interventions

PROCEDURE

Revision Total Knee Arthroplasty (TKA)

Femoral component exchange, tibial component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure. Given the variability in blood loss between types of revision TKA, randomization will be done to ensure equivalent numbers of each type of revision TKA between the treatment groups.

PROCEDURE

Revision Total Hip Arthroplasty (THA)

Femoral component exchange, acetabulum component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure. Given the variability in blood loss between types of revision THA, randomization will be done to ensure equivalent numbers of each type of revision THA between the treatment groups.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Craig J Della Valle, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-08-01
Completion
2019-08-01

Countries

  • United States

Study Locations

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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 NCT02877381 on ClinicalTrials.gov