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Tranexamic Acid for Total Knee Arthroscopy

Primary Purpose

Blood Loss, Surgical

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid (TXA)
Placebo Normal Saline (NS)
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss, Surgical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid (TXA)

Placebo Normal Saline (NS)

Arm Description

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."

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."

Outcomes

Primary Outcome Measures

Assessment of changes in hemostasis via viscoelastic testing.
To compare the magnitude of lysis via lysis indexes.

Secondary Outcome Measures

Hematocrit
The comparison of hematocrit recordings from preoperative period to the postoperative period
Length of Hospitalization
Length of hospital stay from day of surgery to discharge from hospital.
The number of blood transfusions
The number of blood products transfused after surgery
Hospital readmissions
The occurrence of hospital readmissions following surgery

Full Information

First Posted
June 15, 2020
Last Updated
June 19, 2023
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04443920
Brief Title
Tranexamic Acid for Total Knee Arthroscopy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
January 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid (TXA)
Arm Type
Active Comparator
Arm Description
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."
Arm Title
Placebo Normal Saline (NS)
Arm Type
Placebo Comparator
Arm Description
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."
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid (TXA)
Other Intervention Name(s)
Lysteda, Cyklokapron
Intervention Description
Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups
Intervention Type
Drug
Intervention Name(s)
Placebo Normal Saline (NS)
Other Intervention Name(s)
Sodium chloride
Intervention Description
Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups
Primary Outcome Measure Information:
Title
Assessment of changes in hemostasis via viscoelastic testing.
Description
To compare the magnitude of lysis via lysis indexes.
Time Frame
intraoperative (min)
Secondary Outcome Measure Information:
Title
Hematocrit
Description
The comparison of hematocrit recordings from preoperative period to the postoperative period
Time Frame
postoperative day 1
Title
Length of Hospitalization
Description
Length of hospital stay from day of surgery to discharge from hospital.
Time Frame
up to 7 days
Title
The number of blood transfusions
Description
The number of blood products transfused after surgery
Time Frame
90 days
Title
Hospital readmissions
Description
The occurrence of hospital readmissions following surgery
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Snegovskikh, MD
Organizational Affiliation
Rhode Island Hospital; Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23917458
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.
Results Reference
result
PubMed Identifier
24257657
Citation
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.
Results Reference
result
PubMed Identifier
23592025
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 Aug;22(8):1870-8. doi: 10.1007/s00167-013-2492-1. Epub 2013 Apr 17.
Results Reference
result
PubMed Identifier
26559015
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 2015 Nov 12.
Results Reference
result

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Tranexamic Acid for Total Knee Arthroscopy

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