CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 294 enrolled
Drug / intervention
Tranexamic Acid 5%,5ml/amp (intraoperative) +4 moredrug
Likely dose
Tranexamic Acid 5%,5ml/amp (intraoperative)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02458729
NCT02458729Phase 4Completed
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The Blood Saving Effect and Wound-related Complications of Tranexamic Acid in Mininally Invasive Total Knee Arthroplasty With Rivaroxaban as Thromboprophylaxis

Chang Gung Memorial Hospital·interventional·Posted Jun 1, 2015·Updated Jun 1, 2015

In Brief

A Phase 4 clinical trial evaluating Tranexamic Acid 5%,5ml/amp (intraoperative), Tranexamic Acid 5%,5ml/amp (3 hours after operation), and 3 other interventions for Osteoarthritis, Knee. Completed, enrolled 294 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesTaiwan
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 1, 2015
Enrollment StartAug 1, 2012
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.1 years ago

Interventions

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

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

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

tranexamic acid 1g administered intravenously 3 hours after operation

0.9% Normal Saline (intraoperative)drug

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

0.9% Normal Saline (3 hours after operation)drug

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

rivaroxaban (10mg)drug

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