Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829346
• Other study ID #: MTU-EC-OT-0-096/54
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2016
• Last updated: July 11, 2016
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: July 2016
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study evaluates the peri-articular tranexamic acid injection in total knee arthroplasty which is an alternative route of administration for blood loss reduction. Half of participants will receive intravenous tranexamic acid injection, while the other half will receive peri-articular tranexamic acid injection during total knee arthroplasty.

Description:

Intravenous tranexamic acid (IV TXA) is one of the most effective agents in use for reducing blood loss following total knee arthroplasty (TKA) but its safety regarding venous thromboembolic events (VTEs) remains in question. The direct, local application of TXA may reduce systemic toxicity whilst maintaining good or better bleeding control compared to IV TXA. The topical application of TXA via Hemovac drains has been reported previously with good results. However, there are no data on peri-articular TXA injections during TKA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• adult patients with osteoarthritis in need of a TKA

Exclusion Criteria:

• inflammatory arthritis

• post-traumatic arthritis

• a history of or current venous thromboembolic disease

• any underlying disease of haemostasis

• cirrhosis

• chronic renal failure

• patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel)

• know allergy to TXA

• defective color vision

• preoperative hemoglobin <10 g/dL

• platelet count < 140,000 /uL3

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Peri-articular tranexamic acid
750 mg of peri-articular TXA, prior to deflating the tourniquet and wound closure
• Intravenous tranexamic acid
750 mg of IV TXA, prior to deflating the tourniquet and wound closure

Locations

Country	Name	City	State
Thailand	Orthopaedic department, Thammasat university hospital	Klongluang	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

References & Publications (26)

Aggarwal AK, Singh N, Sudesh P. Topical vs Intravenous Tranexamic Acid in Reducing Blood Loss After Bilateral Total Knee Arthroplasty: A Prospective Study. J Arthroplasty. 2015 Dec 21. pii: S0883-5403(15)01114-6. doi:10.1016/j.arth.2015.12.033. [Epub ahead of print]

Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br. 2011 Dec;93(12):1577-85. doi: 10.1302/0301-620X.93B12.26989. Review. — View Citation

Benoni G, Lethagen S, Fredin H. The effect of tranexamic acid on local and plasma fibrinolysis during total knee arthroplasty. Thromb Res. 1997 Feb 1;85(3):195-206. Erratum in: hromb Res 1997 Oct 15;88(2):251. — View Citation

Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22. — View Citation

Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. Review. — View Citation

Eubanks JD. Antifibrinolytics in major orthopaedic surgery. J Am Acad Orthop Surg. 2010 Mar;18(3):132-8. Review. — View Citation

Gonzalez-Porras JR, Colado E, Conde MP, Lopez T, Nieto MJ, Corral M. An individualized pre-operative blood saving protocol can increase pre-operative haemoglobin levels and reduce the need for transfusion in elective total hip or knee arthroplasty. Transfus Med. 2009 Feb;19(1):35-42. doi: 10.1111/j.1365-3148.2009.00908.x. — View Citation

Ishida K, Tsumura N, Kitagawa A, Hamamura S, Fukuda K, Dogaki Y, Kubo S, Matsumoto T, Matsushita T, Chin T, Iguchi T, Kurosaka M, Kuroda R. Intra-articular injection of tranexamic acid reduces not only blood loss but also knee joint swelling after total knee arthroplasty. Int Orthop. 2011 Nov;35(11):1639-45. doi: 10.1007/s00264-010-1205-3. Epub 2011 Jan 21. — View Citation

Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12. Review. — View Citation

Kluft C, Verheijen JH, Jie AF, Rijken DC, Preston FE, Sue-Ling HM, Jespersen J, Aasen AO. The postoperative fibrinolytic shutdown: a rapidly reverting acute phase pattern for the fast-acting inhibitor of tissue-type plasminogen activator after trauma. Scand J Clin Lab Invest. 1985 Nov;45(7):605-10. — View Citation

Maniar RN, Kumar G, Singhi T, Nayak RM, Maniar PR. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res. 2012 Sep;470(9):2605-12. doi: 10.1007/s11999-012-2310-y. Epub 2012 Mar 15. — View Citation

Mannucci PM, Levi M. Prevention and treatment of major blood loss. N Engl J Med. 2007 May 31;356(22):2301-11. Review. — View Citation

Mannucci PM. Hemostatic drugs. N Engl J Med. 1998 Jul 23;339(4):245-53. Review. — View Citation

Manor D, Sadeh M. Muscle fibre necrosis induced by intramuscular injection of drugs. Br J Exp Pathol. 1989 Aug;70(4):457-62. — View Citation

Murphy WG, Davies MJ, Eduardo A. The haemostatic response to surgery and trauma. Br J Anaesth. 1993 Feb;70(2):205-13. Review. — 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

Ortega-Andreu M, Pérez-Chrzanowska H, Figueredo R, Gómez-Barrena E. Blood loss control with two doses of tranexamic Acid in a multimodal protocol for total knee arthroplasty. Open Orthop J. 2011 Mar 16;5:44-8. doi: 10.2174/1874325001105010044. — View Citation

Parvizi J, Diaz-Ledezma C. Total knee replacement with the use of a tourniquet: more pros than cons. Bone Joint J. 2013 Nov;95-B(11 Suppl A):133-4. doi: 10.1302/0301-620X.95B11.32903. — View Citation

Pinsornsak P, Chumchuen S. Can a modified Robert Jones bandage after knee arthroplasty reduce blood loss? A prospective randomized controlled trial. Clin Orthop Relat Res. 2013 May;471(5):1677-81. doi: 10.1007/s11999-013-2786-0. Epub 2013 Jan 11. — View Citation

Pitta M, Zawadsky M, Verstraete R, Rubinstein A. Intravenous administration of tranexamic acid effectively reduces blood loss in primary total knee arthroplasty in a 610-patient consecutive case series. Transfusion. 2016 Feb;56(2):466-71. doi: 10.1111/trf.13354. Epub 2015 Oct 28. — View Citation

Roy SP, Tanki UF, Dutta A, Jain SK, Nagi ON. Efficacy of intra-articular tranexamic acid in blood loss reduction following primary unilateral total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2494-501. doi: 10.1007/s00167-012-1942-5. Epub 2012 Mar 15. — View Citation

Sabatini L, Trecci A, Imarisio D, Uslenghi MD, Bianco G, Scagnelli R. Fibrin tissue adhesive reduces postoperative blood loss in total knee arthroplasty. J Orthop Traumatol. 2012 Sep;13(3):145-51. doi: 10.1007/s10195-012-0198-7. Epub 2012 May 16. — View Citation

Sinclair KC, Clarke HD, Noble BN. Blood management in total knee arthroplasty: a comparison of techniques. Orthopedics. 2009 Jan;32(1):19. — View Citation

Spreng UJ, Dahl V, Hjall A, Fagerland MW, Ræder J. High-volume local infiltration analgesia combined with intravenous or local ketorolac+morphine compared with epidural analgesia after total knee arthroplasty. Br J Anaesth. 2010 Nov;105(5):675-82. doi: 10.1093/bja/aeq232. Epub 2010 Aug 24. — View Citation

Wang H, Shen B, Zeng Y. Blood Loss and Transfusion After Topical Tranexamic Acid Administration in Primary Total Knee Arthroplasty. Orthopedics. 2015 Nov;38(11):e1007-16. doi: 10.3928/01477447-20151020-10. Review. — 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

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The volume of postoperative blood loss in the drain		48 hours after the operation	No
Primary	Changes from baseline hemoglobin concentrations		48 hours after the operation	No
Primary	unit of blood transfusion		48 hours after the operation	No
Secondary	Knee diameter for swelling		At 24 and 48 hours after the operation	Yes
Secondary	number of patient with venous thromboembolism		At 14 days after the operation	Yes