Tranexamic Acid for Total Knee Arthroscopy

NCT04443920 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 1372794
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigation is to determine the most effective regimen of administration of tranexamic acid to improve clinical outcome among patients undergoing total knee arthroplasty.

Conditions

Blood Loss, Surgical

Outcome Measures

Primary Outcomes (1)

• Assessment of changes in hemostasis via viscoelastic testing.

  To compare the magnitude of lysis via lysis indexes.

  intraoperative (min)

Secondary Outcomes (4)

• Hematocrit

  postoperative day 1

• Length of Hospitalization

  up to 7 days

• The number of blood transfusions

  90 days

• Hospital readmissions

  90 days

Study Arms (2)

Tranexamic acid (TXA)

ACTIVE COMPARATOR

All patients will receive 15 mg/kg Tranexamic acid (TXA) IV prior to skin incision. This arm will receive a second intravenous dose of 15 mg/kg of Tranexamic acid (TXA) before the release of the tourniquet. The medication is delivered from the pharmacy in a masked syringe labeled as "study medication."

Drug: Tranexamic acid (TXA)

Placebo Normal Saline (NS)

PLACEBO COMPARATOR

All patients will receive 15 mg/kg Tranexamic acid (TXA) IV prior to skin incision. This arm will receive a second intravenous dose of placebo (Normal Saline) in the volume calculated to be equal to the volume of 15 mg/kg of TXA. The medication is delivered from the pharmacy in a masked syringe labeled as "study medication."

Drug: Placebo Normal Saline (NS)

Interventions

Tranexamic acid (TXA) DRUG

Randomly assigned \[1:1 ratio\] using a computer generated table of random numbers to 1 of the 2 intervention groups

Also known as: Lysteda, Cyklokapron

Tranexamic acid (TXA)

Placebo Normal Saline (NS) DRUG

Randomly assigned \[1:1 ratio\] using a computer generated table of random numbers to 1 of the 2 intervention groups

Also known as: Sodium chloride

Placebo Normal Saline (NS)

Eligibility Criteria

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

You may qualify if:

• \- Adult patients who are scheduled to undergo total knee arthroplasty will be approached to participate.

You may not qualify if:

• Known allergy to TXA
• History of venous or arterial thrombosis within 12 months
• History of thromboembolic event within 12 months
• Acute ischemic event (stroke, transient ischemic attack, myocardial infarction, ischemic retinopathy) within 6 months
• Known congenital thrombophilia
• Relative Contraindications:
• History of seizures
• Impaired kidney function (Glomerular filtration rate \< 30 ml/min)

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (4)

• Pachauri A, Acharya KK, Tiwari AK. The effect of tranexamic acid on hemoglobin levels during total knee arthroplasty. Am J Ther. 2014 Sep-Oct;21(5):366-70. doi: 10.1097/MJT.0b013e318250f85a.

  PMID: 23917458 RESULT

• Aguilera X, Martinez-Zapata MJ, Bosch A, Urrutia G, Gonzalez JC, Jordan M, Gich I, Maymo RM, Martinez N, Monllau JC, Celaya F, Fernandez JA. Efficacy and safety of fibrin glue and tranexamic acid to prevent postoperative blood loss in total knee arthroplasty: a randomized controlled clinical trial. J Bone Joint Surg Am. 2013 Nov 20;95(22):2001-7. doi: 10.2106/JBJS.L.01182.

  PMID: 24257657 RESULT

• Kim TK, Chang CB, Kang YG, Seo ES, Lee JH, Yun JH, Lee SH. Clinical value of tranexamic acid in unilateral and simultaneous bilateral TKAs under a contemporary blood-saving protocol: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1870-8. doi: 10.1007/s00167-013-2492-1. Epub 2013 Apr 17.

  PMID: 23592025 RESULT

• Na HS, Shin HJ, Lee YJ, Kim JH, Koo KH, Do SH. The effect of tranexamic acid on blood coagulation in total hip replacement arthroplasty: rotational thromboelastographic (ROTEM(R)) analysis. Anaesthesia. 2016 Jan;71(1):67-75. doi: 10.1111/anae.13270. Epub 2015 Nov 12.

  PMID: 26559015 RESULT

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

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

Study Officials

• Denis Snegovskikh, MD

  Rhode Island Hospital; Brown University

  PRINCIPAL INVESTIGATOR

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: June 15, 2020
• First Posted: June 23, 2020
• Study Start: October 29, 2019
• Primary Completion: October 7, 2020
• Study Completion: January 8, 2021
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)