Clincosm LogoSign in Get a demo

Tranexamic Acid for Total Knee Arthroscopy

Sponsor
The Miriam Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04443920
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
19.1
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic acid (TXA)
  • Drug: Placebo Normal Saline (NS)
 Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 29, 2019
Anticipated Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
May 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Tranexamic acid (TXA)

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)
Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups
Other Names:
  • Lysteda
  • Cyklokapron

    		•
    Placebo Comparator: Placebo Normal Saline (NS)

    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)
    Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups
    Other Names:
  • Sodium chloride

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of changes in hemostasis via viscoelastic testing. [intraoperative (min)]

      To compare the magnitude of lysis via lysis indexes.

    Secondary Outcome Measures

    1. Hematocrit [postoperative day 1]

      The comparison of hematocrit recordings from preoperative period to the postoperative period

    2. Length of Hospitalization [up to 7 days]

      Length of hospital stay from day of surgery to discharge from hospital.

    3. The number of blood transfusions [90 days]

      The number of blood products transfused after surgery

    4. Hospital readmissions [90 days]

      The occurrence of hospital readmissions following surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Miriam Hospital Providence Rhode Island United States 02903

    Sponsors and Collaborators

    • The Miriam Hospital

    Investigators

    • Principal Investigator: Denis Snegovskikh, MD, Rhode Island Hospital; Brown University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Miriam Hospital
    ClinicalTrials.gov Identifier:
    NCT04443920
    Other Study ID Numbers:
    • 1372794
    First Posted:
    Jun 23, 2020
    Last Update Posted:
    Jun 23, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Blood Loss, Surgical
    Tranexamic Acid

    Study Results

    No Results Posted as of Jun 23, 2020