MedTrace Logo

The Blood Saving Effect of Tranexamic Acid in Total Knee Arthroplasty With Rivaroxaban as Thromboprophylaxis

NCT02458729 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2015-06-01

No results posted yet for this study

Summary

The aim of this study was to conduct a prospective, randomized, double-blind study and assess the efficacy of and safety for thromboprophylaxis of rivaroxaban in total knee arthroplasty patients when tranexamic acid is used for bleeding prophylaxis.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Tranexamic Acid 5%,5ml/amp (intraoperative)

tranexamic acid 1g administered intravenously five minutes before deflation of the tourniquet

DRUG

Tranexamic Acid 5%,5ml/amp (3 hours after operation)

tranexamic acid 1g administered intravenously 3 hours after operation

DRUG

0.9% Normal Saline (intraoperative)

0.9% Normal Saline 20ml administered intravenously five minutes before deflation of the tourniquet

DRUG

0.9% Normal Saline (3 hours after operation)

0.9% Normal Saline 20ml administered intravenously 3 hours after operation

DRUG

rivaroxaban (10mg)

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

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
2012-08-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Taiwan

More Related Trials

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 NCT02458729 on ClinicalTrials.gov