Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty

NCT03328832 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 201601271A0
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Thrombin-gelatin matrix; Floseal; Tranexamic Acid; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Total Blood Loss After Operation

  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 Outcomes (2)

• Blood Transfusion Rate

  From the operation to the postoperative day 3 or 4

• Incidence of Thrombosis Events

  within 30 days of the operation

Study Arms (2)

Combined topical TXA and Floseal

ACTIVE COMPARATOR

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: Topical tranexamic acid; Drug: Floseal®; Drug: rivaroxaban (10mg)

Topical TXA alone

ACTIVE COMPARATOR

Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.

Drug: Topical tranexamic acid; Drug: rivaroxaban (10mg)

Interventions

Topical tranexamic acid DRUG

Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule

Also known as: Topical transamine

Combined topical TXA and Floseal; Topical TXA alone

Floseal® DRUG

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)

Also known as: Thrombin-gelatin matrix

Combined topical TXA and Floseal

rivaroxaban (10mg) DRUG

Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.

Also known as: Xarelto

Combined topical TXA and Floseal; Topical TXA alone

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have advanced knee osteoarthritis are scheduled to undergo primary, unilateral elective total knee replacement surgery
• Age \> 50 years and \< 90 years
• Failure of medical treatment or rehabilitation.
• Hemoglobin \> 11g/dl,
• No use of non-steroid anti-inflammatory agent one week before operation

You may not qualify if:

• Preoperative Hemoglobin ≦11 g/dl
• History of infection or intraarticular fracture of the affective knee
• Renal function deficiency (GFR \<30 ml/min/1.73m2)which is relative contraindicated for chemical venous thromboembolism
• 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)
• History of deep vein thrombosis, ischemic heart disease or stroke
• Contraindications of tranexamic acid, floseal, or rivaroxaban
• Allergy to tranexamic acid, floseal, rivaroxaban, or the excipients
• History of heparin-induced thrombocytopenia (HIT)
• Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc.
• Patient who have active bleeding disorder, such as intracranial hemorrhage, upper GI bleeding, hematuria.
• Patients with known allergies to materials of bovine origin

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (31)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tranexamic Acid; Tranylcypromine; FloSeal Matrix; Rivaroxaban

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Propylamines; Amines; Thiophenes; Sulfur Compounds; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Wang JW
• Organization: Kaohsiung Chang Gung Memorial Hospital

wangjw@adm.cgmh.org.tw

+886-7-7317123

Study Officials

• Jun-Wen Wang, MD

  Chang Gung Memorial Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 1, 2017
• Study Start: September 12, 2017
• Primary Completion: September 30, 2018
• Study Completion: December 30, 2018
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)