Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty

July 19, 2021 updated by: Wang Jun-Wen, Chang Gung Memorial Hospital

Comparison of Combined Topical Tranexamic Acid With Floseal® With Intravenous Tranexamic Acid on Blood Loss in Total Knee Arthroplasty

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty (TKA) is associated with considerable blood loss and increasing needs for allogenic blood transfusion. 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 infusion of TXA reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. There were some reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients.

Besides, thrombin-based hemostatic agents, Floseal®(Baxter, Deerfield, Illinois), have been widely used in surgical procedure. Some recent studies demonstrated that topical use of Floseal® in primary TKA can reduce hemoglobin decline and calculated total blood loss after TKA. But other studies showed Floseal® does not reduce blood loss in TKA procedures.

We believe the topical use of hemostatic agent in patients with high risk of thromboembolism can avoid its systematic effect and decrease its potential perioperative risk of thromboembolic complications (arterial thrombosis, myocardial infarction and pulmonary embolism). Recently, there were some reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients. The blood saving effect of topical application of TXA in primary TKA was similar with systemic administration. The mean total blood loss of topical route of TXA inTKA patients was 940-1295 ml in different reports which was still high for patients with high thromboembolic risks. However, the efficacy and safety of topical use of TXA in TKA patients with history of thromboembolic disease is still unclear. A more effective regimen for bleeding prophylaxis afer primary TKA is necessary.

We believe that combined topical applications of two hemostatic agents of different mechanisms can bring a synergistic effect in blood saving and does not increase the risk of thromboembolic disease after TKA.

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.

Study Type

Interventional

Enrollment (Actual)

70

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
        • Kaohsiung Chang Gung Memorial Hospital

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:

  1. Patients who have advanced knee osteoarthritis are scheduled to undergo primary, unilateral elective total knee replacement surgery
  2. Age > 50 years and < 90 years
  3. Failure of medical treatment or rehabilitation.
  4. Hemoglobin > 11g/dl,
  5. No use of non-steroid anti-inflammatory agent one week 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)which is relative contraindicated for chemical venous thromboembolism
  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
  6. Contraindications of tranexamic acid, floseal, or rivaroxaban
  7. Allergy to tranexamic acid, floseal, 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.
  11. Patients with known allergies to materials of bovine origin

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
ACTIVE_COMPARATOR: Combined topical TXA and Floseal
Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
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)
Other Names:
  • Thrombin-gelatin matrix
Drug: Topical tranexamic acid
Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Other Names:
  • Topical transamine
Drug: rivaroxaban (10mg)
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Other Names:
  • Xarelto
ACTIVE_COMPARATOR: Topical TXA alone
Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Drug: Topical tranexamic acid
Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Other Names:
  • Topical transamine
Drug: rivaroxaban (10mg)
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Other Names:
  • Xarelto

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Blood Loss After Operation
Time Frame: From the operation to the postoperative day 3 or 4
Total blood loss was calculated according to Nadler et al., which used maximum postoperative reduction of the Hb level adjust for weight and height of the patient. The formula is as follows, Total blood loss = (Total blood volume x [change in Hb level / preoperative Hb level])x1000+volume transfused
From the operation to the postoperative day 3 or 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Transfusion Rate
Time Frame: From the operation to the postoperative day 3 or 4
We will record the event of blood transfusion, and calculate the incidence of transfusion
From the operation to the postoperative day 3 or 4
Incidence of Thrombosis Events
Time Frame: within 30 days of the operation
The composite of any venous thromoembolism events, ischemic heart attacks, cerebrovascular accidents
within 30 days of the 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)

September 12, 2017

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

December 30, 2018

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (ACTUAL)

November 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201601271A0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used and analyzed in the study are available on request to the corresponding author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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