Tranexamic Acid Study
2. oktober 2015 opdateret af: Texas Tech University Health Sciences Center
Randomized Placebo Controlled Study Using Tranexamic Acid in Revision Total Hip Arthroplasty
The purpose of this study is to determine if tranexamic acid significantly reduces blood loss and blood transfusion in revision total hip replacement.
Tranexamic acid is a drug that helps to reduce blood loss during surgery.
Revision total hip replacement surgery is treatment for patients who have previously had hipe replacement surgery which failed and must be repaired/replaced.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Tranexamic acid is an anti-fibrinolytic agent that inhibits fibrinolysis leading to a reduction of blood loss without concurrently increasing the risk of thromboembolic complications. Several studies have shown that tranexamic acid reduces blood loss and blood transfusions in primary total hip and knee arthroplasty. However, there have not been any studies that evaluate its efficacy in revision total hip arthroplasty. The significance of this study is that the need for blood transfusions and their complications may be minimized in revision hip arthroplasty if tranexamic acid is found to significantly decrease the amount of blood transfusions.
After the patient has been consented, he or she will be randomized into one of two groups (tranexamic acid and placebo) by the School of Pharmacy. The placebo will be crystalloid fluid of equal volume as tranexamic acid. The patient will then undergo revision total hip arthroplasty by Dr. Rosenstein and be administered tranexamic acid or placebo. Blood loss will be recorded intraoperatively and postoperatively through drains. Criteria for blood transfusion include hemoglobin less than 10g/dl or hematocrit less than 30%. Once the operation ends, the drug or placebo will be discontinued and the postoperative care is unchanged from current standards/protocols. Intraoperative blood loss, total blood loss, and number of blood transfusions will be recorded and analyzed. Length of acute hospital stay will also be recorded. A cost analysis will be performed comparing tranexamic acid to blood transfusions.
Undersøgelsestype
Interventionel
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Texas
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Lubbock, Texas, Forenede Stater, 79430
- Texas Tech University Health Sciences Center Department of Orthopaedic Surgery
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Failed primary total hip arthroplasty (femoral stem, acetabular component, or both)
- 18-100 years of age
Exclusion Criteria:
- Prosthetic infection
- Primary total hip arthroplasty
- Prisoners
- Pregnancy
- Previous adverse reaction to tranexamic acid
- Bleeding/coagulation disorders
- Renal insufficiency (serum creatinine>two standard deviations for age)
- History of deep venous thrombosis or pulmonary embolism
- Religious beliefs/practices prohibiting blood transfusions
- Wards of the state
- Cognitively impaired patients
- Terminally ill patients
- Students and/or employees
- Color blindness
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Introperative blood loss
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Total blood loss
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Number of blood transfusions required
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Sekundære resultatmål
Resultatmål |
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Length of acute hospital stay
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Alexander D Rosenstein, MD, Texas Tech University Health Sciences Center Department of Orthopaedic Surgery
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- Hiippala ST, Strid LJ, Wennerstrand MI, Arvela JV, Niemela HM, Mantyla SK, Kuisma RP, Ylinen JE. Tranexamic acid radically decreases blood loss and transfusions associated with total knee arthroplasty. Anesth Analg. 1997 Apr;84(4):839-44. doi: 10.1097/00000539-199704000-00026.
- Ho KM, Ismail H. Use of intravenous tranexamic acid to reduce allogeneic blood transfusion in total hip and knee arthroplasty: a meta-analysis. Anaesth Intensive Care. 2003 Oct;31(5):529-37. doi: 10.1177/0310057X0303100507.
- Husted H, Blond L, Sonne-Holm S, Holm G, Jacobsen TW, Gebuhr P. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients. Acta Orthop Scand. 2003 Dec;74(6):665-9. doi: 10.1080/00016470310018171.
- Yamasaki S, Masuhara K, Fuji T. Tranexamic acid reduces blood loss after cementless total hip arthroplasty-prospective randomized study in 40 cases. Int Orthop. 2004 Apr;28(2):69-73. doi: 10.1007/s00264-003-0511-4. Epub 2003 Oct 10.
- Ekback G, Axelsson K, Ryttberg L, Edlund B, Kjellberg J, Weckstrom J, Carlsson O, Schott U. Tranexamic acid reduces blood loss in total hip replacement surgery. Anesth Analg. 2000 Nov;91(5):1124-30. doi: 10.1097/00000539-200011000-00014.
- Ido K, Neo M, Asada Y, Kondo K, Morita T, Sakamoto T, Hayashi R, Kuriyama S. Reduction of blood loss using tranexamic acid in total knee and hip arthroplasties. Arch Orthop Trauma Surg. 2000;120(9):518-20. doi: 10.1007/s004029900132.
- Garneti N, Field J. Bone bleeding during total hip arthroplasty after administration of tranexamic acid. J Arthroplasty. 2004 Jun;19(4):488-92. doi: 10.1016/j.arth.2003.12.073.
- Benoni G, Fredin H, Knebel R, Nilsson P. Blood conservation with tranexamic acid in total hip arthroplasty: a randomized, double-blind study in 40 primary operations. Acta Orthop Scand. 2001 Oct;72(5):442-8. doi: 10.1080/000164701753532754.
- Lemay E, Guay J, Cote C, Roy A. Tranexamic acid reduces the need for allogenic red blood cell transfusions in patients undergoing total hip replacement. Can J Anaesth. 2004 Jan;51(1):31-7. doi: 10.1007/BF03018543.
- Benoni G, Lethagen S, Nilsson P, Fredin H. Tranexamic acid, given at the end of the operation, does not reduce postoperative blood loss in hip arthroplasty. Acta Orthop Scand. 2000 Jun;71(3):250-4. doi: 10.1080/000164700317411834.
- D'Ambrosio A, Borghi B, Damato A, D'Amato G, Antonacci D, Valeri F. Reducing perioperative blood loss in patients undergoing total hip arthroplasty. Int J Artif Organs. 1999 Jan;22(1):47-51.
- Hayes A, Murphy DB, McCarroll M. The efficacy of single-dose aprotinin 2 million KIU in reducing blood loss and its impact on the incidence of deep venous thrombosis in patients undergoing total hip replacement surgery. J Clin Anesth. 1996 Aug;8(5):357-60. doi: 10.1016/0952-8180(96)00080-3.
- Janssens M, Joris J, David JL, Lemaire R, Lamy M. High-dose aprotinin reduces blood loss in patients undergoing total hip replacement surgery. Anesthesiology. 1994 Jan;80(1):23-9. doi: 10.1097/00000542-199401000-00007.
- Jeserschek R, Clar H, Aigner C, Rehak P, Primus B, Windhager R. Reduction of blood loss using high-dose aprotinin in major orthopaedic surgery: a prospective, double-blind, randomised and placebo-controlled study. J Bone Joint Surg Br. 2003 Mar;85(2):174-7. doi: 10.1302/0301-620x.85b2.13303.
- Kasper SM, Elsner F, Hilgers D, Grond S, Rutt J. A retrospective study of the effects of small-dose aprotinin on blood loss and transfusion needs during total hip arthroplasty. Eur J Anaesthesiol. 1998 Nov;15(6):669-75. doi: 10.1097/00003643-199811000-00008.
- Langdown AJ, Field J, Grote J, Himayat H. Aprotinin (Trasylol) does not reduce bleeding in primary total hip arthroplasty. J Arthroplasty. 2000 Dec;15(8):1009-12. doi: 10.1054/arth.2000.8102.
- Murkin JM, Shannon NA, Bourne RB, Rorabeck CH, Cruickshank M, Wyile G. Aprotinin decreases blood loss in patients undergoing revision or bilateral total hip arthroplasty. Anesth Analg. 1995 Feb;80(2):343-8. doi: 10.1097/00000539-199502000-00023.
- Murkin JM, Haig GM, Beer KJ, Cicutti N, McCutchen J, Comunale ME, Hall R, Ruzicka BB. Aprotinin decreases exposure to allogeneic blood during primary unilateral total hip replacement. J Bone Joint Surg Am. 2000 May;82(5):675-84. doi: 10.2106/00004623-200005000-00008.
- Walsh TS, McClelland DB. When should we transfuse critically ill and perioperative patients with known coronary artery disease? Br J Anaesth. 2003 Jun;90(6):719-22. doi: 10.1093/bja/aeg109. No abstract available.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2005
Primær færdiggørelse (Faktiske)
1. januar 2008
Studieafslutning (Faktiske)
1. januar 2008
Datoer for studieregistrering
Først indsendt
11. september 2006
Først indsendt, der opfyldte QC-kriterier
11. september 2006
Først opslået (Skøn)
13. september 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. oktober 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. oktober 2015
Sidst verificeret
1. oktober 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- L05-063
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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