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Comparison of Topical and Infusion Tranexamic Acid After Total Knee Arthroplasty

NCT02453802 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2015-05-27

No results posted yet for this study

Summary

The purpose of the study, therefore, is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of TXA in different TKA patients groups with rivaroxaban for VTE prophylaxis, first group by topical application, second group by infusion and a third group of placebo and observe whether there is difference in the occurrence of venous thromboembolism in those patient groups by venographic study

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Tranexamic Acid 5%,5ml/amp

Intraarticular application of tranexamic acid 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule

DRUG

Tranexamic Acid 5%,5ml/amp

IV TXA group: Primary total knee replacement with 1 g tranexamic acid administrated intravenously before deflection of the tourniquet

DRUG

rivaroxaban (10mg)

Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.

DRUG

0.9% Normal Saline

Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet

DRUG

0.9% Normal Saline

Topical 160 ml normal saline application after closure of joint capsule.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Jun-Wen Wang, MD · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Taiwan

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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 NCT02453802 on ClinicalTrials.gov