Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty

NCT03825939 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: WUH 592498-2
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR).

Conditions

Blood Loss

Keywords

Total hip arthroplasty; Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Required a Blood Transfusion During Surgery

  Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

  operative period (average of 1 hour)

Secondary Outcomes (5)

• Change in Levels of Hematocrit: Pre-operative to Post-operative

  Day 3 or 4 post surgery

• Length of Hospital Stay

  At Hospital Discharge

• Estimated Blood Loss During Surgery

  Operative period (an average of 1 hour)

• Change in Hemoglobin: Pre-operative to Post-operative

  Day 3 or 4 post surgery

• Walking Distance Post Total Joint Arthroplasty of the Hip

  4 Days

Study Arms (3)

Intravenous Tranexamic Acid

EXPERIMENTAL

* 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery

Drug: Intravenous Tranexamic Acid

Intravenous Placebo

PLACEBO COMPARATOR

\- IV 0.9% sterile saline

Drug: Intravenous Placebo

Intravenous Tranexamic Acid followed by Intravenous Placebo

ACTIVE COMPARATOR

* 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery * IV 0.9% sterile saline

Drug: Intravenous Placebo; Drug: Intravenous Tranexamic Acid

Interventions

Intravenous Placebo DRUG

IV 0.9% sterile saline

Also known as: Saline

Intravenous Placebo; Intravenous Tranexamic Acid followed by Intravenous Placebo

Intravenous Tranexamic Acid DRUG

1g TXA IVPB (intravenous piggyback)

Also known as: Tranexamic Acid

Intravenous Tranexamic Acid; Intravenous Tranexamic Acid followed by Intravenous Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients 18 years and older who are already scheduled for primary total joint arthroplasty of the hip or knee

You may not qualify if:

• Cardiac stent or ischemic stroke or coronary artery bypass graft (CABG)
• If patient is on anticoagulant, patient must have documented approval from a cardiologist that patient can be removed from anticoagulant for total joint arthroplasty procedure
• Renal impairment defined as serum Cr \> 1.5 or Cr Clearance \< 50 mL/min
• Severe ischemic heart disease
• Color blindness or problems with color vision
• Criteria for Use of Topical TXA
• History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
• Known congenital thrombophilia
• History of thromboembolic or vascular disease
• Disseminated intravascular coagulation (DIC)
• History of seizures

Sponsors & Collaborators

• NYU Langone Health: lead
• Winthrop University Hospital: collaborator

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Related Publications (22)

• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

  PMID: 17403800 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

• Pedersen AB, Mehnert F, Overgaard S, Johnsen SP. Allogeneic blood transfusion and prognosis following total hip replacement: a population-based follow up study. BMC Musculoskelet Disord. 2009 Dec 29;10:167. doi: 10.1186/1471-2474-10-167.

  PMID: 20040083 BACKGROUND

• Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.

  PMID: 22611164 BACKGROUND

• Sukeik M, Alshryda S, Haddad FS, Mason JM. Systematic review and meta-analysis of the use of tranexamic acid in total hip replacement. J Bone Joint Surg Br. 2011 Jan;93(1):39-46. doi: 10.1302/0301-620X.93B1.24984.

  PMID: 21196541 BACKGROUND

• Panteli M, Papakostidis C, Dahabreh Z, Giannoudis PV. Topical tranexamic acid in total knee replacement: a systematic review and meta-analysis. Knee. 2013 Oct;20(5):300-9. doi: 10.1016/j.knee.2013.05.014. Epub 2013 Jun 28.

  PMID: 23815893 BACKGROUND

• Orpen NM, Little C, Walker G, Crawfurd EJ. Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients. Knee. 2006 Mar;13(2):106-10. doi: 10.1016/j.knee.2005.11.001. Epub 2006 Feb 17.

  PMID: 16487712 BACKGROUND

• Johansson T, Pettersson LG, Lisander B. Tranexamic acid in total hip arthroplasty saves blood and money: a randomized, double-blind study in 100 patients. Acta Orthop. 2005 Jun;76(3):314-9.

  PMID: 16156456 BACKGROUND

• Niskanen RO, Korkala OL. Tranexamic acid reduces blood loss in cemented hip arthroplasty: a randomized, double-blind study of 39 patients with osteoarthritis. Acta Orthop. 2005 Dec;76(6):829-32. doi: 10.1080/17453670510045444.

  PMID: 16470437 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

• Camarasa MA, Olle G, Serra-Prat M, Martin A, Sanchez M, Ricos P, Perez A, Opisso L. Efficacy of aminocaproic, tranexamic acids in the control of bleeding during total knee replacement: a randomized clinical trial. Br J Anaesth. 2006 May;96(5):576-82. doi: 10.1093/bja/ael057. Epub 2006 Mar 10.

  PMID: 16531440 BACKGROUND

• Chang CH, Chang Y, Chen DW, Ueng SW, Lee MS. Topical tranexamic acid reduces blood loss and transfusion rates associated with primary total hip arthroplasty. Clin Orthop Relat Res. 2014 May;472(5):1552-7. doi: 10.1007/s11999-013-3446-0. Epub 2014 Jan 3.

  PMID: 24385043 BACKGROUND

• Martin JG, Cassatt KB, Kincaid-Cinnamon KA, Westendorf DS, Garton AS, Lemke JH. Topical administration of tranexamic acid in primary total hip and total knee arthroplasty. J Arthroplasty. 2014 May;29(5):889-94. doi: 10.1016/j.arth.2013.10.005. Epub 2013 Oct 16.

  PMID: 24238825 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

• Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on transfusion rate in primary total hip arthroplasty. J Arthroplasty. 2014 Feb;29(2):387-9. doi: 10.1016/j.arth.2013.05.026. Epub 2013 Jun 21.

  PMID: 23790499 BACKGROUND

• Gilbody J, Dhotar HS, Perruccio AV, Davey JR. Topical tranexamic acid reduces transfusion rates in total hip and knee arthroplasty. J Arthroplasty. 2014 Apr;29(4):681-4. doi: 10.1016/j.arth.2013.09.005. Epub 2013 Oct 4.

  PMID: 24095586 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

• Gillette BP, DeSimone LJ, Trousdale RT, Pagnano MW, Sierra RJ. Low risk of thromboembolic complications with tranexamic acid after primary total hip and knee arthroplasty. Clin Orthop Relat Res. 2013 Jan;471(1):150-4. doi: 10.1007/s11999-012-2488-z.

  PMID: 22814857 BACKGROUND

• Fu DJ, Chen C, Guo L, Yang L. Use of intravenous tranexamic acid in total knee arthroplasty: a meta-analysis of randomized controlled trials. Chin J Traumatol. 2013;16(2):67-76.

  PMID: 23540893 BACKGROUND

• Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873.

  PMID: 22623147 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Sodium Chloride; Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Jan Koenig
• Organization: NYU Langone

Jan.Koenig@nyulangone.org

516-678-2232

Study Officials

• Jan A Koenig, M.D.

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: February 1, 2019
• Study Start: April 21, 2015
• Primary Completion: July 26, 2016
• Study Completion: September 6, 2016
• Last Updated: September 28, 2021
• Results First Posted: September 28, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)