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Tranexamic Acid for Unilateral Total Knee Arthroplasty

NCT01594671 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-12-19

No results posted yet for this study

Summary

Total knee arthroplasty is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to determine the peri-operative bleeding comparing the application of topical and intravenous tranexamic acid with the habitual surgical haemostasis.

Conditions

  • Blood Loss

Interventions

DRUG

Tranexamic Acid

Two dosage during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage. Each dosage: 2 ampoules of 500mg/5 mL/ampoule

DRUG

Tranexamic Acid

One dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.

OTHER

haemostasia

The surgical habitual haemostasia: electrocoagulation of the bleeding tissues

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Principal Investigators

  • Aguilera X, M.D · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  • Martinez-Zapata MJ, PhD · Centro Cochrane Iberoamericano. IIB Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Spain

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 NCT01594671 on ClinicalTrials.gov