Kaolin-based Hemostatic Gauze in Total Knee Arthroplasty

NCT05504577 | Unknown Phase 4 FDA Device

• 1 other identifier: CMRPG8M0261
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Blood Loss; Arthropathy of Knee Joint

Keywords

Postoperative blood loss; Total knee arthroplasty; kaolin-impregnated gauze; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Total Blood Loss

  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 Outcomes (2)

• Blood transfusion rate

  To three months after operation

• All symptomatic thrombotic events including deep vein thrombosis, pulmonary embolism

  To three months after operation

Study Arms (3)

QCG group

EXPERIMENTAL

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; Device: apply the QCG

Surgical gauze group

ACTIVE COMPARATOR

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; Device: apply surgical gauze

Control group

PLACEBO COMPARATOR

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

Interventions

Tranexamic acid injection DRUG

Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .

Also known as: transamine injection

Control group; QCG group; Surgical gauze group

apply the QCG DEVICE

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

QCG group

apply surgical gauze DEVICE

apply the normal surgical gauze into the joint space. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes

Surgical gauze group

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 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

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 (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, in which life-long oral anticoagulant are required.
• Contraindications of tranexamic acid, or rivaroxaban
• Allergy to tranexamic acid, kaolin, 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..

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Related Publications (28)

• Bong MR, Patel V, Chang E, Issack PS, Hebert R, Di Cesare PE. Risks associated with blood transfusion after total knee arthroplasty. J Arthroplasty. 2004 Apr;19(3):281-7. doi: 10.1016/j.arth.2003.10.013.

  PMID: 15067638 BACKGROUND

• Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002.

  PMID: 9973048 BACKGROUND

• Goodnough LT, Verbrugge D, Marcus RE. The relationship between hematocrit, blood lost, and blood transfused in total knee replacement. Implications for postoperative blood salvage and reinfusion. Am J Knee Surg. 1995 Summer;8(3):83-7.

  PMID: 7552610 BACKGROUND

• Tanaka N, Sakahashi H, Sato E, Hirose K, Ishima T, Ishii S. Timing of the administration of tranexamic acid for maximum reduction in blood loss in arthroplasty of the knee. J Bone Joint Surg Br. 2001 Jul;83(5):702-5. doi: 10.1302/0301-620x.83b5.11745.

  PMID: 11476309 BACKGROUND

• Alvarez JC, Santiveri FX, Ramos I, Vela E, Puig L, Escolano F. Tranexamic acid reduces blood transfusion in total knee arthroplasty even when a blood conservation program is applied. Transfusion. 2008 Mar;48(3):519-25. doi: 10.1111/j.1537-2995.2007.01564.x. Epub 2007 Dec 7.

  PMID: 18067499 BACKGROUND

• Petaja J, Myllynen P, Myllyla G, Vahtera E. Fibrinolysis after application of a pneumatic tourniquet. Acta Chir Scand. 1987 Nov-Dec;153(11-12):647-51.

  PMID: 3124428 BACKGROUND

• Kambayashi J, Sakon M, Yokota M, Shiba E, Kawasaki T, Mori T. Activation of coagulation and fibrinolysis during surgery, analyzed by molecular markers. Thromb Res. 1990 Oct 15;60(2):157-67. doi: 10.1016/0049-3848(90)90294-m.

  PMID: 2149215 BACKGROUND

• Hiippala S, Strid L, Wennerstrand M, Arvela V, Mantyla S, Ylinen J, Niemela H. Tranexamic acid (Cyklokapron) reduces perioperative blood loss associated with total knee arthroplasty. Br J Anaesth. 1995 May;74(5):534-7. doi: 10.1093/bja/74.5.534.

  PMID: 7772427 BACKGROUND

• Benoni G, Fredin H. Fibrinolytic inhibition with tranexamic acid reduces blood loss and blood transfusion after knee arthroplasty: a prospective, randomised, double-blind study of 86 patients. J Bone Joint Surg Br. 1996 May;78(3):434-40.

  PMID: 8636182 BACKGROUND

• Lin PC, Hsu CH, Chen WS, Wang JW. Does tranexamic acid save blood in minimally invasive total knee arthroplasty? Clin Orthop Relat Res. 2011 Jul;469(7):1995-2002. doi: 10.1007/s11999-011-1789-y. Epub 2011 Feb 1.

  PMID: 21286886 BACKGROUND

• Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.

  PMID: 21048170 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

• 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

• 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

• 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

• Yen SH, Lin PC, Chen B, Huang CC, Wang JW. Topical Tranexamic Acid Reduces Blood Loss in Minimally Invasive Total Knee Arthroplasty Receiving Rivaroxaban. Biomed Res Int. 2017;2017:9105645. doi: 10.1155/2017/9105645. Epub 2017 Dec 19.

  PMID: 29410968 BACKGROUND

• Rajagopalan V, Chouhan RS, Pandia MP, Lamsal R, Rath GP. Effect of Intraoperative Blood Loss on Perioperative Complications and Neurological Outcome in Adult Patients Undergoing Elective Brain Tumor Surgery. J Neurosci Rural Pract. 2019 Oct;10(4):631-640. doi: 10.1055/s-0039-3399487. Epub 2019 Dec 11.

  PMID: 31831982 BACKGROUND

• Walsh PN. The effects of collagen and kaolin on the intrinsic coagulant activity of platelets. Evidence for an alternative pathway in intrinsic coagulation not requiring factor XII. Br J Haematol. 1972 Apr;22(4):393-405. doi: 10.1111/j.1365-2141.1972.tb05687.x. No abstract available.

  PMID: 5028124 BACKGROUND

• Gegel BT, Austin PN, Johnson AD. An evidence-based review of the use of a combat gauze (QuikClot) for hemorrhage control. AANA J. 2013 Dec;81(6):453-8.

  PMID: 24597007 BACKGROUND

• Motamedi MH, Sagafinia M. QuickClot combat gauze use for hemorrhage control in military trauma. Prehosp Disaster Med. 2011 Jun;26(3):237. doi: 10.1017/S1049023X11006273. No abstract available.

  PMID: 22107778 BACKGROUND

• Travers S, Lefort H, Ramdani E, Lemoine S, Jost D, Bignand M, Tourtier JP. Hemostatic dressings in civil prehospital practice: 30 uses of QuikClot Combat Gauze. Eur J Emerg Med. 2016 Oct;23(5):391-4. doi: 10.1097/MEJ.0000000000000318.

  PMID: 26351975 BACKGROUND

• Shina A, Lipsky AM, Nadler R, Levi M, Benov A, Ran Y, Yitzhak A, Glassberg E. Prehospital use of hemostatic dressings by the Israel Defense Forces Medical Corps: A case series of 122 patients. J Trauma Acute Care Surg. 2015 Oct;79(4 Suppl 2):S204-9. doi: 10.1097/TA.0000000000000720.

  PMID: 26406432 BACKGROUND

• Trabattoni D, Gatto P, Bartorelli AL. A new kaolin-based hemostatic bandage use after coronary diagnostic and interventional procedures. Int J Cardiol. 2012 Apr 5;156(1):53-4. doi: 10.1016/j.ijcard.2010.10.030. Epub 2010 Nov 18.

  PMID: 21087799 BACKGROUND

• Derkay CS, Baydoun HA, Stone L. Intraoperative Use of QuikClot During Adenotonsillectomy: A Prospective Pediatric Trial. Ann Otol Rhinol Laryngol. 2015 May;124(5):384-91. doi: 10.1177/0003489414560432. Epub 2014 Nov 25.

  PMID: 25423961 BACKGROUND

• Patel SA, Martin M, Chamales I. Vaginal hemorrhage from transobturator sling controlled with QuikClot combat gauze. Mil Med. 2012 Aug;177(8):997-8. doi: 10.7205/milmed-d-11-00429.

  PMID: 22934384 BACKGROUND

• Schmid BC, Rezniczek GA, Rolf N, Maul H. Postpartum hemorrhage: use of hemostatic combat gauze. Am J Obstet Gynecol. 2012 Jan;206(1):e12-3. doi: 10.1016/j.ajog.2011.09.018. Epub 2011 Sep 24.

  PMID: 22011588 BACKGROUND

• Abbott EM, Nandyala SV, Schwend RM. Does a kaolin-impregnated hemostatic dressing reduce intraoperative blood loss and blood transfusions in pediatric spinal deformity surgery? Spine (Phila Pa 1976). 2014 Sep 1;39(19):E1174-80. doi: 10.1097/BRS.0000000000000466.

  PMID: 24921838 BACKGROUND

• Kim K, Shim H, Jung PY, Kim S, Choi YU, Bae KS, Lee JK, Jang JY. Effectiveness of kaolin-impregnated hemostatic gauze use in preperitoneal pelvic packing for patients with pelvic fractures and hemodynamic instability: A propensity score matching analysis. PLoS One. 2020 Jul 24;15(7):e0236645. doi: 10.1371/journal.pone.0236645. eCollection 2020.

  PMID: 32706824 BACKGROUND

MeSH Terms

Conditions

Exsanguination; Postoperative Hemorrhage

Interventions

Tranexamic Acid; Tranylcypromine

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Propylamines; Amines

Study Officials

• Jun-Wen Wang, MD

  Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Shih-Hsiang Yen, MD

CONTACT

886-7-7317123; yswings@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: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: March 16, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: September 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)