Tranexamic Acid Study

NCT ID: NCT00375440

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2008-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Arthroplasty, Replacement, Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Tranexamic Acid

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Principal Investigators

Alexander D Rosenstein, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center Department of Orthopaedic Surgery

Locations

Texas Tech University Health Sciences Center Department of Orthopaedic Surgery

Lubbock, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10919295 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11728069 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10098585 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11049894 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15188109 (View on PubMed)

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.

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PMID: 8832445 (View on PubMed)

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.

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Reference Type: BACKGROUND

PMID: 14763696 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 11011672 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7507304 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12678347 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9884852 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11112196 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14709457 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7529467 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10819278 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 15224162 (View on PubMed)

Other Identifiers

L05-063

Identifier Type: -

Identifier Source: org_study_id