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

Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03825939
• Other study ID #: WUH 592498-2
• Status: Terminated
• Phase: Phase 4
• Start date: April 21, 2015
• Est. completion date: September 6, 2016

Study information

• Verified date: August 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Tranexamic Acid (TXA) is given to stop or reduce heavy bleeding. It works by stopping clots from breaking down and by decreasing unwanted bleeding. It is used in many types of surgeries to help reduce surgical complications such as blood loss and blood transfusions.

In orthopaedic surgeries, such as in total hip and knee replacements, TXA has been shown to effectively reduce blood loss and transfusion requirements without an increased risk of side effects such as deep venous thrombosis (DVT) or pulmonary embolism (PE). The ability to decrease blood loss is crucial, as other studies have shown that reducing blood loss decreases morbidity and mortality in patients.

Although, many TXA dosing regimens have been studied - all of which have been useful at reducing blood loss and decreasing transfusion requirements - the best TXA dosing regimen and the most cost-effective method of TXA administration for patients have yet to be determined. Moreover, a thorough and rigorous study on the use and effects of topical and intravenous TXA and the effect of TXA on patient outcomes has yet to be conducted.

Therefore, this research study aims to address those concerns in order to understand how best to use TXA to reduce surgical complications in patients undergoing total joint replacements.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: September 6, 2016
• Est. primary completion date: July 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

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

Exclusion Criteria for IV TXA administration

• 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

• Topical TXA can be used in any patient meeting one of the exclusion criteria for IV TXA administration (Section 5.3b) as there is minimal systemic absorption with topical TXA

Absolute Exclusion Criteria

• 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

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Drug:
• Intravenous Placebo
IV 0.9% sterile saline
• Intravenous Tranexamic Acid
1g TXA IVPB (intravenous piggyback)

Locations

Country	Name	City	State
United States	Winthrop University Hospital	Mineola	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Winthrop University Hospital

Country where clinical trial is conducted

United States, 

References & Publications (22)

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. Epub 2007 Dec 7. — View Citation

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. — View Citation

Camarasa MA, Ollé G, Serra-Prat M, Martín A, Sánchez M, Ricós P, Pérez 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. Epub 2006 Mar 10. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Feb 17. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Levels of Hematocrit: Pre-operative to Post-operative	Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.	Day 3 or 4 post surgery
Secondary	Length of Hospital Stay	Measured in Days	At Hospital Discharge
Secondary	Estimated Blood Loss During Surgery	Surgeon estimated blood loss	Operative period (an average of 1 hour)
Secondary	Change in Hemoglobin: Pre-operative to Post-operative	Measured in grams/deciliter	Day 3 or 4 post surgery
Secondary	Walking Distance Post Total Joint Arthroplasty of the Hip	Walking distance (feet) will be assessed and documented throughout the hospital stay	4 Days