Kaolin-based Hemostatic Gauze in Total Knee Arthroplasty

September 7, 2022 updated by: Chang Gung Memorial Hospital

Blood-saving Effect of Kaolin-based Hemostatic Gauze Combined With Intravenous Tranexamic Acid in Total Knee Arthroplasty

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty (TKA) is associated with considerable blood loss and increasing needs for allogenic blood transfusion. Previous studies demonstrated a transfusion rates ranging from 10% to 38% after standard TKAs. Tranexamic acid (TXA), an inhibitor of fibrinolysis, was reportedly effective reducing blood loss after standard TKA. Our previous experiences in minimally invasive (MIS) TKA showed that intraoperative intravenous infusion of TXA reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. Our study demonstrated that an equal efficacy of intraarticular topical TXA in blood conservation compared with intravenous infusion of TXA.

In addition to TXA, the Quikclot sponge (QCG; Z-Medica, Wallingford, CT, USA) is a newly developed hemostatic agent employing an inorganic mineral (kaolin). The QCG has predominantly been used in combat settings and trauma surgery. Recently, the application of QCG in interventional procedures, and non-orthopedic surgeries was reported. Literature describing the use of QCG as an alternative approach to achieve hemostasis in the field of orthopedics is limited. There is no study to investigate the blood-saving effect of QCG in a TKA procedure, especially in combined with TKA. Therefore we conduct the study to understand the efficacy of this sponge on blood conservation in TKA We believe that combination with the two different mechanism of blood-conservation agents can bring a synergistic effect in blood saving after TKA. Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of QCG combined with TXA use.

Material and Methods:

The patients who are enrolled in this study will be randomly assigned into three groups. We plan to recruit 60 patients in each group (total case number is 120). The first group will be treated by application of QCG in joint space and TXA 1g intravenous injection before tourniquet deflation. The second group will be treated by application of normal gauze in joint space and TXA 1g intravenous injection before tourniquet deflation. The third group will be treated only TXA 1g intravenously injection alone before tourniquet deflation. We will observe whether there is difference in the blood-conservation effect by total blood loss calculation, hemoglobin loss and transfusion requirement between these three groups. Besides, any complications including VTE, deep infection, wound complications within postoperative 3 months will be recorded.

Study years: two years

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with advanced osteoarthritis of the knee and undergo primary unilateral minimally invasive TKA
  • Age > 50 years and < 90 years
  • Failure of medical treatment or rehabilitation
  • Hemoglobin ≧ 11g/dl
  • No use of non-steroid anti-inflammatory agent, antiplatelets or anticoagulants at least 3 days before operation

Exclusion Criteria:

  1. Preoperative Hemoglobin <11 g/dl
  2. History of infection or intraarticular fracture of the affective knee
  3. Renal function deficiency (GFR <30 ml/min/1.73m2)
  4. Elevated liver enzyme (AST/ALT level are more than twice normal range) , history of liver cirrhosis, impaired liver function(elevated total bilirubin level) and coagulopathy (including long-term use anticoagulant)
  5. History of deep vein thrombosis, ischemic heart disease or stroke, in which life-long oral anticoagulant are required.
  6. Contraindications of tranexamic acid, or rivaroxaban
  7. Allergy to tranexamic acid, kaolin, rivaroxaban, or the excipients
  8. History of heparin-induced thrombocytopenia (HIT)
  9. Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc.
  10. Patient who have active bleeding disorder, such as intracranial hemorrhage, upper GI bleeding, hematuria..

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: QCG group
After the prosthesis are all implanted, apply the QCG (Quikclot Z-fold hemostatic gauze, Z-Medica, Wallingford, CT, USA) into the joint space. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes, then remove the QCG from the knee joint and throughout check bleeders before closure of the joint capsule. Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation
Drug: Tranexamic acid injection
Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .
Other Names:
  • transamine injection
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
ACTIVE_COMPARATOR: Surgical gauze group
After the prosthesis are all implanted, apply the surgical gauze into the joint space. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes, then remove the gauze from the joint and throughout check bleeders before closure of the joint capsule. Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation
Drug: Tranexamic acid injection
Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .
Other Names:
  • transamine injection
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
PLACEBO_COMPARATOR: Control group
fter the prosthesis are all implanted, we close the joint capsule directly. Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .
Drug: Tranexamic acid injection
Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .
Other Names:
  • transamine injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Blood Loss
Time Frame: Preoperative day to postoperative day 4
The total blood loss was calculated according to Nadler et al, which uses maximum postoperative decrease of the Hb level adjusted for weight and height of the patient. Total blood loss consists of amount of blood loss calculated from the maximum Hb loss and amount of blood transfused
Preoperative day to postoperative day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood transfusion rate
Time Frame: To three months after operation
We will record the event of blood transfusion, and calculate the incidence of transfusion
To three months after operation
All symptomatic thrombotic events including deep vein thrombosis, pulmonary embolism
Time Frame: To three months after operation
We will record all symptomatic thrombotic events including deep vein thrombosis, pulmonary embolism in our study, and calculate the incidence of them
To three months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2022

Primary Completion (ANTICIPATED)

July 31, 2023

Study Completion (ANTICIPATED)

July 31, 2023

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (ACTUAL)

August 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG8M0261

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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