MedTrace Logo

Kaolin-based Hemostatic Gauze in Total Knee Arthroplasty

NCT05504577 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-09-10

No results posted yet for this study

Summary

This study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combination of intravenous TXA and QCG in a primary TKA procedure.

Conditions

  • Total Blood Loss
  • Arthropathy of Knee Joint

Interventions

DRUG

Tranexamic acid injection

Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .

DEVICE

apply the QCG

apply the QCG (Quikclot Z-fold hemostatic gauze, Z-Medica, Wallingford, CT, USA) into the joint space. Compress the knee joint by elastic bandage. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes

DEVICE

apply surgical gauze

apply the normal surgical gauze into the joint space. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Jun-Wen Wang, MD · Department of Orthopaedic Surgery, Kaohsiung 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
2022-03-16
Primary Completion
2023-07-31
Completion
2023-07-31
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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 NCT05504577 on ClinicalTrials.gov