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Topical Tranexamic Acid and Floseal® in Total Knee Arthroplasty

NCT02865174 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-08-12

No results posted yet for this study

Summary

Our purpose of this study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of this two topical hemostatic agents in primary TKA procedures in patients with a risk of thromboembolic events. We will also observe if there is increased risk of thromboembolism by use of topical hemostatic agents.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Topical tranexamic acid

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

DRUG

Floseal®

Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)

DRUG

Enoxaparin

Enoxaparin will be administrated sc 40mg each day postoperatively as venous thromboembolism prophylaxis in the duration of hospital stay

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Jun-Wen Wang · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-08-31
Completion
2017-08-31

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 NCT02865174 on ClinicalTrials.gov