Topical Tranexamic Acid and Floseal® in Total Knee Arthroplasty

NCT02865174 | Unknown Phase 4 DMC

• 1 other identifier: NMMRPG8F0191
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Our purpose of this study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of this two topical hemostatic agents in primary TKA procedures in patients with a risk of thromboembolic events. We will also observe if there is increased risk of thromboembolism by use of topical hemostatic agents.

Conditions

Osteoarthritis, Knee

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• Decrease of hemoglobin level after operation

  We will check hemoglobin preoperatively and postop. Day 1, 2, 3 or 4 and 14. We will calculate the change of hemoglobin level on postoperative day 1, 2, 4, and 14.

  From the operation to the postoperative day 14

Secondary Outcomes (4)

• Incidence of major postoperative bleeding

  within 30 days of the operation

• Incidence of any non-major bleeding

  within 30 days of the operation

• Incidence of wound infection after surgery

  within 30 days of the operation

• Incidence of any thrombotic events

  within 30 days of the operation

Study Arms (3)

Topical tranexamic acid

ACTIVE COMPARATOR

Intraarticular application of tranexamic acid Enoxaparin for venous thromboembolism prophylaxis in the duration of hospital stay

Drug: Topical tranexamic acid; Drug: Enoxaparin

Floseal®

ACTIVE COMPARATOR

Floseal® was applied on potential bleeding sites before prosthesis implantation. Enoxaparin for venous thromboembolism prophylaxis in the duration of hospital stay

Drug: Floseal®; Drug: Enoxaparin

Control group

PLACEBO COMPARATOR

No intervention before closure of joint capsule. Enoxaparin for venous thromboembolism prophylaxis in the duration of hospital stay

Drug: Enoxaparin

Interventions

Topical tranexamic acid DRUG

Intraarticular application of tranexamic acid 3g in 100 ml normal saline into knee joint after closure of the joint capsule

Also known as: Topical transamine

Topical tranexamic acid

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

Floseal®

Enoxaparin DRUG

Enoxaparin will be administrated sc 40mg each day postoperatively as venous thromboembolism prophylaxis in the duration of hospital stay

Also known as: Low molecular weight heparin

Control group; Floseal®; Topical tranexamic acid

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of ischemic heart disease, stroke, or VTE high risk group, such as obesity, varicose vein of the leg, previous history of PE or DVT, hypercoagulability, recent or ongoing treatment for cancer.
• After cardiologist or neurologist's evaluation, patients who was classified as low-risk of perioperative risk Advanced knee osteoarthritis, 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) Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Koahsiung, Taiwan, Taiwan

Location

Related Publications (15)

• Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1937-44. doi: 10.2106/JBJS.N.00060.

  PMID: 25471907 BACKGROUND

• Schwab PE, Thienpont E. Use of a haemostatic matrix does not reduce blood loss in minimally invasive total knee arthroplasty. Blood Transfus. 2015 Jul;13(3):435-41. doi: 10.2450/2015.0199-14. Epub 2015 Jan 26.

  PMID: 25761324 BACKGROUND

• Helito CP, Gobbi RG, Castrillon LM, Hinkel BB, Pecora JR, Camanho GL. Comparison of Floseal(r) and electrocautery in hemostasis after total knee arthroplasty. Acta Ortop Bras. 2013;21(6):320-2. doi: 10.1590/S1413-78522013000600004.

  PMID: 24453689 BACKGROUND

• Comadoll JL, Comadoll S, Hutchcraft A, Krishnan S, Farrell K, Kreuwel HT, Bechter M. Comparison of hemostatic matrix and standard hemostasis in patients undergoing primary TKA. Orthopedics. 2012 Jun;35(6):e785-93. doi: 10.3928/01477447-20120525-14.

  PMID: 22691647 BACKGROUND

• Kim HJ, Fraser MR, Kahn B, Lyman S, Figgie MP. The efficacy of a thrombin-based hemostatic agent in unilateral total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012 Jul 3;94(13):1160-5. doi: 10.2106/JBJS.K.00531.

  PMID: 22623075 BACKGROUND

• Suarez JC, Slotkin EM, Alvarez AM, Szubski CR, Barsoum WK, Patel PD. Prospective, randomized trial to evaluate efficacy of a thrombin-based hemostatic agent in total knee arthroplasty. J Arthroplasty. 2014 Oct;29(10):1950-5. doi: 10.1016/j.arth.2014.05.025. Epub 2014 Jun 5.

  PMID: 25015756 BACKGROUND

• Di Francesco A, Flamini S, Fiori F, Mastri F. Hemostatic matrix effects on blood loss after total knee arthroplasty: A randomized controlled trial. Indian J Orthop. 2013 Sep;47(5):474-81. doi: 10.4103/0019-5413.118203.

  PMID: 24133307 BACKGROUND

• Testini M, Marzaioli R, Lissidini G, Lippolis A, Logoluso F, Gurrado A, Lardo D, Poli E, Piccinni G. The effectiveness of FloSeal matrix hemostatic agent in thyroid surgery: a prospective, randomized, control study. Langenbecks Arch Surg. 2009 Sep;394(5):837-42. doi: 10.1007/s00423-009-0497-5. Epub 2009 May 7.

  PMID: 19421770 BACKGROUND

• Clapp M, Huang JC. Use of FloSeal Sealant in the Surgical Management of Tubal Ectopic Pregnancy. Case Rep Obstet Gynecol. 2013;2013:906825. doi: 10.1155/2013/906825. Epub 2013 May 29.

  PMID: 23819082 BACKGROUND

• Gazzeri R, Galarza M, Alfier A. Safety biocompatibility of gelatin hemostatic matrix (Floseal and Surgiflo) in neurosurgical procedures. Surg Technol Int. 2012 Dec;22:49-54.

  PMID: 22915500 BACKGROUND

• Georgiadis AG, Muh SJ, Silverton CD, Weir RM, Laker MW. A prospective double-blind placebo controlled trial of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):78-82. doi: 10.1016/j.arth.2013.03.038. Epub 2013 Jul 29.

  PMID: 23906869 BACKGROUND

• Konig G, Hamlin BR, Waters JH. Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty. J Arthroplasty. 2013 Oct;28(9):1473-6. doi: 10.1016/j.arth.2013.06.011. Epub 2013 Jul 23.

  PMID: 23886406 BACKGROUND

• Chimento GF, Huff T, Ochsner JL Jr, Meyer M, Brandner L, Babin S. An evaluation of the use of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):74-7. doi: 10.1016/j.arth.2013.06.037.

  PMID: 24034510 BACKGROUND

• Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1080-3. doi: 10.1016/j.arth.2012.11.016. Epub 2013 Mar 28.

  PMID: 23541868 BACKGROUND

• Yen SH, Lin PC, Wu CT, Wang JW. Comparison of Effects of a Thrombin-Based Hemostatic Agent and Topical Tranexamic Acid on Blood Loss in Patients with Preexisting Thromboembolic Risk Undergoing a Minimally Invasive Total Knee Arthroplasty. A Prospective Randomized Controlled Trial. Biomed Res Int. 2021 Jan 14;2021:2549521. doi: 10.1155/2021/2549521. eCollection 2021.

  PMID: 33511201 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tranexamic Acid; Tranylcypromine; FloSeal Matrix; Enoxaparin; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Propylamines; Amines; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Jun-Wen Wang

  Chang Gung Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Jun-Wen MD Wang

CONTACT

886-7-7317123; wangjw@adm.cgmh.org.tw

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: Wang Jun-Wen [wang0155]

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 12, 2016

Record last verified: 2016-08

Locations

TW (1)