Tranexamic Acid in Knee Joint Surgery

NCT02278263 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-05-20

Study results available
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Summary

Total knee joint replacement surgery can lead to significant blood loss, which can affect recovery after surgery. Tranexamic acid (TXA) is a medication which stops the breakdown of blood clots and therefore prevents blood loss. The optimal use of TXA remains a point of debate. Growing interest in the topical application of TXA (directly into the surgical wound) has been suggested as an alternative way of administering TXA, and may demonstrate similar effectiveness as when it is given intravenously. Therefore, this multicentred, randomized controlled trial, aims to investigate the safety and effectiveness of both topical and intravenous administrations of TXA in total knee joint surgery. The investigators predict that both routes of administration will demonstrate similar results when compared to placebo.

Conditions

Interventions

DRUG

Tranexamic Acid

Given intravenously or topically

DRUG

Normal saline (0.9% NaCl)

Administered in all 3 groups

Sponsors & Collaborators

  • Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS

    lead OTHER

Principal Investigators

  • Jacob T Munro, MBChB, FRACS · Department of Surgery, The University of Auckland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-11-30
Completion
2016-03-31

Countries

  • New Zealand

Study Locations

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Entities

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 NCT02278263 on ClinicalTrials.gov