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Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03328832
Recruitment Status : Unknown
Verified April 2017 by Wang Jun-Wen, Chang Gung Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 1, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Wang Jun-Wen, Chang Gung Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Topical tranexamic acid Drug: Floseal® Drug: rivaroxaban (10mg) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Comparison of Combined Topical Tranexamic Acid With Floseal® With Intravenous Tranexamic Acid on Blood Loss in Total Knee Arthroplasty
Estimated Study Start Date : November 12, 2017
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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: Topical tranexamic acid
Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Other Name: Topical transamine

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 Name: Thrombin-gelatin matrix

Drug: rivaroxaban (10mg)
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Other Name: 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 Name: Topical transamine

Drug: rivaroxaban (10mg)
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Other Name: Xarelto




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Incidence of thrombosis events [ Time Frame: within 30 days of the operation ]
    The composite of any venous thromoembolism events, ischemic heart attacks, cerebrovascular accidents



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328832


Contacts
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Contact: Jun-Wen Wang, MD 886-7-7317123 wangjw@adm.cgmh.org.tw

Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital Not yet recruiting
Kaohsiung, Taiwan
Contact: Jun-Wen Wang, MD    886-7-7317123    wangjw@adm.cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Jun-Wen Wang, MD Chang Gung Memorial Hospital

Publications:

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Responsible Party: Wang Jun-Wen, Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03328832     History of Changes
Other Study ID Numbers: 201601271A0
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Wang Jun-Wen, Chang Gung Memorial Hospital:
Thrombin-gelatin matrix
Floseal
Tranexamic Acid
Total Knee Arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Rivaroxaban
Tranexamic Acid
Thrombin
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants