Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Rush University Medical Center
Sponsor:
Information provided by (Responsible Party):
Brett Levine, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01651806
First received: May 1, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This includes having a greater impact on decreasing blood loss without increasing the occurrence of adverse thromboembolic events in patients undergoing primary, elective total knee arthroplasty.

Secondary - TA will decrease blood loss more effectively in women than in men undergoing this procedure.


Condition Intervention Phase
Osteoarthritis
Intraoperative Bleeding
Drug: Tranexamic Acid
Drug: Females receiving a uniform dose of TA
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty, a Randomized-clinical Trial.

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Primary intra-operative blood loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Record intra-operative blood loss through drain output and number of dressing changes, number of transfusions, as well as changes in hemoglobin and hematocrit levels.

  • Document incidences of DVT and other thromboembolic events. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Outcomes post-operative swelling [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Determine post-operative swelling by measuring thigh and leg circumference pre-operatively and post-operatively on day 1 and day 2, as well as at 2 week, 6 week, and 3 month follow-up.

  • Evaluate range of motion at discharge, as well as at 2 week, 6 week, and 3 month follow-up [ Time Frame: discharge, week 2, week 6, 3 month followup ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Females receiving a uniform dose of TA
Women receiving a single dose of 1 gram of TA--includes all women that will get 1 gram dose of the TA during surgery. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
Drug: Females receiving a uniform dose of TA
Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.
Other Name: Tranexamic Acid
Active Comparator: Weighted dose of TA in female patients
Female patients receiving a weighted dose of TA. Will include all women that will get a weighted dose of the TA during surgery. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
Drug: Tranexamic Acid
Weighted dose--20mg/kg of the drug will be given
Other Name: TA
Active Comparator: Tranexamic acid weighted dose male
Male patients randomized to the weighted dose of TA. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
Drug: Tranexamic Acid
Weighted dose--20mg/kg of the drug will be given
Other Name: TA
Active Comparator: Uniform single dose TA male patient
Male patients receiving a single dose (1gram) of TA during TKA. Includes all men that will get 1 gram dose of the TA during surgery. Postop outcomes wil be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Drug: Tranexamic Acid
Uniform 1 gram dosing
Other Name: TA

Detailed Description:

Overall Study Design

Study design and control methods:

This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a single uniform 1 g dose of TA and a single weighted 20 mg/kg dose of tranexamic acid (TA).

Treatment group:

The subjects will be randomly assigned to the uniform dose group or weighted dose group at the time of the surgery via the opening of a randomly selected closed envelope. The patient and the independent reviewer will be blinded as to the dose of TA utilized during the surgery. This information will be linked to a confidential database for later review by the principal investigator.

Treatment allocation:

All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired.

Trial Population

Target population:

The target sample size is 60 patients of each of the uniform and weighted dose groups (120 total) with each group split evenly between males and females. There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 120 subjects experiencing joint pain that warrants a TKA. The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 120 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients must be male or female of any race
  2. Ages 18-80 years old
  3. Patients must be undergoing an elective, primary knee arthroplasty
  4. Patients must be able to understand and willing to cooperate with study procedures
  5. Patients must be able to provide written and verbal informed consent

Exclusion Criteria:

  1. Allergy or intolerance to the study materials
  2. History of a venous thromboembolic event being treated with life-long anticoagulation
  3. Patients with a known congenital thrombophilia
  4. Patients who have had a venous thromboembolic event within the 12 months preceding surgery
  5. History of any substance abuse or dependence within the last 6 months
  6. Failure in collecting a required data point during study
  7. Those patients not indicated for knee replacement surgery including, pregnant women, those not cleared medically for the procedure and patients without significant radiographic evidence of degenerative joint disease.
  8. Patient using autologous blood transfusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651806

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Brett R Levine, MD    312-432-2466    brettlevinemd@gmail.com   
Contact: Mark Belkin, BS    3124322466    mbelkin3@gmail.com   
Principal Investigator: Brett R Levine, MD, MS         
Sponsors and Collaborators
Rush University Medical Center
Investigators
Study Director: Mark Belkin, BS Rush University Medical Center
  More Information

Publications:
Responsible Party: Brett Levine, MD, Assistant Professor and Associate Residency Director, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01651806     History of Changes
Other Study ID Numbers: 12021202
Study First Received: May 1, 2012
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Blood loss
transfusion rates
complications

Additional relevant MeSH terms:
Osteoarthritis
Blood Loss, Surgical
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hemorrhage
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014