Blood Loss Reduction After Total Knee Arthroplasty. Comparison Topical Tranexamic Acid vs Platelet Rich Plasma

NCT02650856 | Completed Phase 3 Results DMC

• 1 other identifier: OR15-007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will include patients who will be schedule for total knee arthroplasty with a diagnosis of osteoarthritis. The patients will be divided in two groups. In both groups a verbal and clear detailed information will be given on the intraoperative approach. The first group will receive topical tranexamic acid and the second group topical platelet rich plasma; both in the surgical site. Both groups will be assessed before and after the intervention with laboratory results (hemoglobin, hematocrit levels) and drainage drain.

Conditions

Osteoarthritis

Keywords

Blood loss; Tranexamic acid; Platelet rich plasma; Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Therapeutic Effect on Hemoglobin Level

  The blood test will be taken at 6am every day. Using the same laboratory parameters.

  up to 3rd day post operative (Baseline, 24, 48 and 72hrs)

Secondary Outcomes (2)

• Therapeutic Effect on Hematocrit Level

  up to 3rd day post operative (Baseline, 24, 48 and 72hrs)

• Therapeutic Effect on Drainage Quantification

  up to 2nd day post operative (24 and 48 hrs)

Study Arms (2)

Group 1 Tranexamic acid

EXPERIMENTAL

A dosis of 2 gr of tranexamic acid (1000mg/10ml X-GEN pharmaceuticals inc.) diluted in 80ml of physiologic solution and will be divided in two applications. First application: 40ml of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction. Second application: The rest of 40ml of solution previously prepared is applied after placing the final TKR components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction.

Drug: Group 1 Tranexamic Acid

Group 2 Platelet rich plasma

ACTIVE COMPARATOR

A final volumen of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications. First application: 8 ml of PRP are applied over the surgical site and are left for five minutes then drained out completely by suction. Second application: The rest of the 8 ml are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining.

Biological: Group 2 Platelet rich plasma

Interventions

Group 1 Tranexamic Acid DRUG

2 gr of tranexamic acid will be applied on the surgical site.

Also known as: Topic Tranexamic Acid

Group 1 Tranexamic acid

Group 2 Platelet rich plasma BIOLOGICAL

16ml of platelet rich plasma will be applied of the surgical site

Also known as: PRP

Group 2 Platelet rich plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Patient candidates for primary total knee replacement
• Patients willing to participate in the study and sign de inform consent

You may not qualify if:

• Patients with previous history of thromboembolic event in the last 6 months
• Patients candidates for revision total knee replacement
• Patients candidates for tumoral total knee replacement
• Patients candidates for bilateral total knee replacement
• Patient with cognitive deficit
• Previous history of coagulopathy

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Facultad de Medicina UANL

Monterrey, Nuevo León, 1-4469, Mexico

Location

Related Publications (16)

• Levine BR, Haughom B, Strong B, Hellman M, Frank RM. Blood management strategies for total knee arthroplasty. J Am Acad Orthop Surg. 2014 Jun;22(6):361-71. doi: 10.5435/JAAOS-22-06-361.

  PMID: 24860132 BACKGROUND

• Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1080-3. doi: 10.1016/j.arth.2012.11.016. Epub 2013 Mar 28.

  PMID: 23541868 BACKGROUND

• Frisch NB, Wessell NM, Charters MA, Yu S, Jeffries JJ, Silverton CD. Predictors and complications of blood transfusion in total hip and knee arthroplasty. J Arthroplasty. 2014 Sep;29(9 Suppl):189-92. doi: 10.1016/j.arth.2014.03.048. Epub 2014 May 24.

  PMID: 25007727 BACKGROUND

• Moskal JT, Harris RN, Capps SG. Transfusion cost savings with tranexamic acid in primary total knee arthroplasty from 2009 to 2012. J Arthroplasty. 2015 Mar;30(3):365-8. doi: 10.1016/j.arth.2014.10.008. Epub 2014 Oct 12.

  PMID: 25458093 BACKGROUND

• CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

  PMID: 20554319 BACKGROUND

• Sheth U, Simunovic N, Klein G, Fu F, Einhorn TA, Schemitsch E, Ayeni OR, Bhandari M. Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis. J Bone Joint Surg Am. 2012 Feb 15;94(4):298-307. doi: 10.2106/JBJS.K.00154.

  PMID: 22241606 BACKGROUND

• Patel JN, Spanyer JM, Smith LS, Huang J, Yakkanti MR, Malkani AL. Comparison of intravenous versus topical tranexamic acid in total knee arthroplasty: a prospective randomized study. J Arthroplasty. 2014 Aug;29(8):1528-31. doi: 10.1016/j.arth.2014.03.011. Epub 2014 Mar 21.

  PMID: 24768543 BACKGROUND

• Chimento GF, Huff T, Ochsner JL Jr, Meyer M, Brandner L, Babin S. An evaluation of the use of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):74-7. doi: 10.1016/j.arth.2013.06.037.

  PMID: 24034510 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

• Sarzaeem MM, Razi M, Kazemian G, Moghaddam ME, Rasi AM, Karimi M. Comparing efficacy of three methods of tranexamic acid administration in reducing hemoglobin drop following total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1521-4. doi: 10.1016/j.arth.2014.02.031. Epub 2014 Mar 6.

  PMID: 24726174 BACKGROUND

• Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908.

  PMID: 24196467 BACKGROUND

• Pace TB, Foret JL, Palmer MJ, Tanner SL, Snider RG. Intraoperative platelet rich plasma usage in total knee arthroplasty: does it help? ISRN Orthop. 2013 Jul 28;2013:740173. doi: 10.1155/2013/740173. eCollection 2013.

  PMID: 24971180 BACKGROUND

• Morishita M, Ishida K, Matsumoto T, Kuroda R, Kurosaka M, Tsumura N. Intraoperative platelet-rich plasma does not improve outcomes of total knee arthroplasty. J Arthroplasty. 2014 Dec;29(12):2337-41. doi: 10.1016/j.arth.2014.04.007. Epub 2014 Apr 13.

  PMID: 24851794 BACKGROUND

• Aggarwal AK, Shashikanth VS, Marwaha N. Platelet-rich plasma prevents blood loss and pain and enhances early functional outcome after total knee arthroplasty: a prospective randomised controlled study. Int Orthop. 2014 Feb;38(2):387-95. doi: 10.1007/s00264-013-2136-6. Epub 2013 Oct 11.

  PMID: 24114251 BACKGROUND

• Bloomfield MR, Klika AK, Molloy RM, Froimson MI, Krebs VE, Barsoum WK. Prospective randomized evaluation of a collagen/thrombin and autologous platelet hemostatic agent during total knee arthroplasty. J Arthroplasty. 2012 May;27(5):695-702. doi: 10.1016/j.arth.2011.09.014. Epub 2011 Oct 27.

  PMID: 22035976 BACKGROUND

• Gardner MJ, Demetrakopoulos D, Klepchick PR, Mooar PA. The efficacy of autologous platelet gel in pain control and blood loss in total knee arthroplasty. An analysis of the haemoglobin, narcotic requirement and range of motion. Int Orthop. 2007 Jun;31(3):309-13. doi: 10.1007/s00264-006-0174-z. Epub 2006 Jul 1.

  PMID: 16816947 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Osteoarthritis; Hemorrhage

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: FELIX VILCHEZ CAVAZOS
• Organization: Universidad Autonoma de Nuevo Leon

vilchez.doctor@gmail.com

8183476698

Study Officials

• Felix Vilchez, MD, PHD

  Hospital Universitario, Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. José Félix Vilchez Cavazos

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: January 8, 2016
• Study Start: September 1, 2015
• Primary Completion: March 9, 2017
• Study Completion: March 9, 2017
• Last Updated: May 26, 2021
• Results First Posted: February 27, 2020

Record last verified: 2021-05

Locations

ME (1)