Kaolin-based Hemostatic Gauze in Total Knee Arthroplasty
NCT ID: NCT05504577
Last Updated: 2022-09-10
Study Results
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Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2022-03-16
2023-07-31
Brief Summary
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Detailed Description
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In addition to TXA, the Quikclot sponge (QCG; Z-Medica, Wallingford, CT, USA) is a newly developed hemostatic agent employing an inorganic mineral (kaolin). The QCG has predominantly been used in combat settings and trauma surgery. Recently, the application of QCG in interventional procedures, and non-orthopedic surgeries was reported. Literature describing the use of QCG as an alternative approach to achieve hemostasis in the field of orthopedics is limited. There is no study to investigate the blood-saving effect of QCG in a TKA procedure, especially in combined with TKA. Therefore we conduct the study to understand the efficacy of this sponge on blood conservation in TKA We believe that combination with the two different mechanism of blood-conservation agents can bring a synergistic effect in blood saving after TKA. Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of QCG combined with TXA use.
Material and Methods:
The patients who are enrolled in this study will be randomly assigned into three groups. We plan to recruit 60 patients in each group (total case number is 120). The first group will be treated by application of QCG in joint space and TXA 1g intravenous injection before tourniquet deflation. The second group will be treated by application of normal gauze in joint space and TXA 1g intravenous injection before tourniquet deflation. The third group will be treated only TXA 1g intravenously injection alone before tourniquet deflation. We will observe whether there is difference in the blood-conservation effect by total blood loss calculation, hemoglobin loss and transfusion requirement between these three groups. Besides, any complications including VTE, deep infection, wound complications within postoperative 3 months will be recorded.
Study years: two years
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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QCG group
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
Tranexamic acid injection
Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .
apply the QCG
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
Surgical gauze group
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
Tranexamic acid injection
Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .
apply surgical gauze
apply the normal surgical gauze into the joint space. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes
Control group
fter the prosthesis are all implanted, we close the joint capsule directly. Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .
Tranexamic acid injection
Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .
Interventions
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Tranexamic acid injection
Tranexamic acid 1g is intravenously injected at 10 mins before tourniquet deflation. .
apply the QCG
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
apply surgical gauze
apply the normal surgical gauze into the joint space. Compress the knee joint by elastic bandage. Deflate the tourniquet for 10 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
2. History of infection or intraarticular fracture of the affective knee
3. Renal function deficiency (GFR \<30 ml/min/1.73m2)
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, in which life-long oral anticoagulant are required.
6. Contraindications of tranexamic acid, or rivaroxaban
7. Allergy to tranexamic acid, kaolin, 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..
50 Years
90 Years
ALL
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Jun-Wen Wang, MD
Role: STUDY_DIRECTOR
Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital
Locations
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CMRPG8M0261
Identifier Type: -
Identifier Source: org_study_id
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