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Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty

NCT03328832 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-08-10

Study results available
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Summary

Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combined topical application of these two hemostatic agents in different time during surgery and the safety compared with single topical application of TKA in a primary TKA procedure

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Topical tranexamic acid

Intraarticular application of tranexamic acid 3g in 60 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

rivaroxaban (10mg)

Oral rivaroxaban (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
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2018-09-30
Completion
2018-12-30
FDA Drug
Yes

Countries

  • Taiwan

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 NCT03328832 on ClinicalTrials.gov