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

Primary Purpose

Osteoarthritis, Intraoperative Bleeding

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid standard dose
Females Tranexamic Acid weighted dose
Females receiving a uniform dose of TA
Males Weighted Dose TA
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Blood loss, transfusion rates, complications

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Females receiving a uniform dose of TA

Weighted dose of TA in female patients

Tranexamic acid weighted dose male

Uniform single dose TA male patient

Historical Cohort

Arm Description

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.

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.

Male patients randomized to the weighted dose of TA. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.

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.

25 patients with no TA use in their surgical history. A control group was established from a historical cohort of primary TKAs performed by the senior author (BL), none of which received TA. The most relevant Pubmed ID would be 24997651.

Outcomes

Primary Outcome Measures

Primary Intra-operative Blood Loss
Record intra-operative blood loss through drain output
Document Incidences of DVT and Other Thromboembolic Events.
DVT = Deep Venous thrombosis Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2012
Last Updated
December 12, 2017
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01651806
Brief Title
Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty
Official Title
Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty, a Randomized-clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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). 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. Results from randomized patients will be compared to a historical control arm that did not receive TA in their treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Intraoperative Bleeding
Keywords
Blood loss, transfusion rates, complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Females receiving a uniform dose of TA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Weighted dose of TA in female patients
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tranexamic acid weighted dose male
Arm Type
Active Comparator
Arm Description
Male patients randomized to the weighted dose of TA. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
Arm Title
Uniform single dose TA male patient
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Historical Cohort
Arm Type
No Intervention
Arm Description
25 patients with no TA use in their surgical history. A control group was established from a historical cohort of primary TKAs performed by the senior author (BL), none of which received TA. The most relevant Pubmed ID would be 24997651.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid standard dose
Other Intervention Name(s)
Male TA
Intervention Description
Uniform 1 gram dosing
Intervention Type
Drug
Intervention Name(s)
Females Tranexamic Acid weighted dose
Other Intervention Name(s)
TA
Intervention Description
Weighted dose--20mg/kg of the drug will be given
Intervention Type
Drug
Intervention Name(s)
Females receiving a uniform dose of TA
Other Intervention Name(s)
Tranexamic Acid
Intervention Description
Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.
Intervention Type
Drug
Intervention Name(s)
Males Weighted Dose TA
Other Intervention Name(s)
Transexamic Acid
Intervention Description
Weighted dose--20mg/kg of the drug will be given
Primary Outcome Measure Information:
Title
Primary Intra-operative Blood Loss
Description
Record intra-operative blood loss through drain output
Time Frame
Intra-operative, an average of 3 hours
Title
Document Incidences of DVT and Other Thromboembolic Events.
Description
DVT = Deep Venous thrombosis Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients must be male or female of any race Ages 18-80 years old Patients must be undergoing an elective, primary knee arthroplasty Patients must be able to understand and willing to cooperate with study procedures Patients must be able to provide written and verbal informed consent Exclusion Criteria: Allergy or intolerance to the study materials History of a venous thromboembolic event being treated with life-long anticoagulation Patients with a known congenital thrombophilia Patients who have had a venous thromboembolic event within the 12 months preceding surgery History of any substance abuse or dependence within the last 6 months Failure in collecting a required data point during study 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. Patient using autologous blood transfusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Belkin, BS
Organizational Affiliation
Rush University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19007970
Citation
Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12.
Results Reference
background
PubMed Identifier
14763696
Citation
Husted H, Blond L, Sonne-Holm S, Holm G, Jacobsen TW, Gebuhr P. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients. Acta Orthop Scand. 2003 Dec;74(6):665-9. doi: 10.1080/00016470310018171.
Results Reference
background
PubMed Identifier
20063079
Citation
Ralley FE, Berta D, Binns V, Howard J, Naudie DD. One intraoperative dose of tranexamic Acid for patients having primary hip or knee arthroplasty. Clin Orthop Relat Res. 2010 Jul;468(7):1905-11. doi: 10.1007/s11999-009-1217-8. Epub 2010 Jan 9. Erratum In: Clin Orthop Relat Res. 2010 May;468(5):1447.
Results Reference
background

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

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