Tranexamic Acid for Total Knee Arthroscopy

Blood Loss, Surgical Clinical Trial

Official title:

Comparison of the Effect of Two Common Regimens of Administration of Tranexamic Acid on Hemostasis and Clinical Outcome of Patients Undergoing Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04443920
• Other study ID #: 1372794
• Status: Completed
• Phase: Phase 4
• Start date: October 29, 2019
• Est. completion date: January 8, 2021

Study information

• Verified date: June 2023
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Tranexamic acid (TXA) is synthetic lysine analog, which acts as anti-fibrinolytic agent by preventing conversion of plasminogen in to plasmin. Various regimens of TXA administration (routes, doses, timing) have been used to decrease perioperative blood loss and improve clinical outcomes among patients undergoing different orthopedic surgeries. We are conducting this prospective randomized placebo controlled trial to compare the effect of the two most common regimens of TXA administration on hemostasis and clinical outcomes among patients undergoing total knee arthroplasty. All recruited patients receive the first dose of 15mg/kg of IV TXA prior to skin incision. The second dose of 15mg/kg IV TXA or identical placebo is administered prior to the release of the tourniquet. The assessment of hemostasis is performed using whole blood sample via viscoelastic testing by rotational thromboelastography (ROTEM). A blood sample is collected in the preoperative area and after the administration of each dose of TXA. Clinical data is collected until 90 days after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 8, 2021
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Blood Loss, Surgical

Intervention

Drug:
• Tranexamic acid (TXA)
Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups
• Placebo Normal Saline (NS)
Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups

Locations

Country	Name	City	State
United States	Miriam Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 arthropla — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of changes in hemostasis via viscoelastic testing.	To compare the magnitude of lysis via lysis indexes.	intraoperative (min)
Secondary	Hematocrit	The comparison of hematocrit recordings from preoperative period to the postoperative period	postoperative day 1
Secondary	Length of Hospitalization	Length of hospital stay from day of surgery to discharge from hospital.	up to 7 days
Secondary	The number of blood transfusions	The number of blood products transfused after surgery	90 days
Secondary	Hospital readmissions	The occurrence of hospital readmissions following surgery	90 days