Back to resultsReducing Hemarthrosis in ACL Reconstruction With BTB Autograft by the Administration of Intravenous TXA
Primary Purpose
Anterior Cruciate Ligament Reconstruction
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Reconstruction
Eligibility Criteria
Inclusion Criteria:
-PATIENTS UNDERGOING AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT
Exclusion Criteria:
- Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
- Younger than 18 years of age
- Any patient considered a vulnerable subject
- Have bleeding or clotting disorder
- Preoperative anticoagulation therapy
- Abnormal coagulation profile
- Renal disorder or insufficiency
- Sickle cell disease
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
ACL Reconstruction w/ BTB Autograft + IV TXA
ACL Reconstruction w/ BTB Autograft, no IV TXA
Arm Description
Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients received two individual doses of intravenous TXA intra-operatively.
Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients did not receive two individual doses of intravenous TXA intra-operatively. Only the consented surgery was performed.
Outcomes
Primary Outcome Measures
POST-OPERATIVE HEMARTHROSIS
Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration.
POST-OPERATIVE Opioid Consumption
Each patient's opioid consumption was measured by morphine milligram equivalents (MME).
POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS)
Pain severity, measured by the Visual Analog Scale (VAS): a scale of 1-10, with 1 being the least amount of pain and 10 being the most amount of pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03631355
Brief Title
Reducing Hemarthrosis in ACL Reconstruction With BTB Autograft by the Administration of Intravenous TXA
Official Title
Reducing Hemarthrosis in Anterior Cruciate Ligament Reconstruction With BTB Autograft by the Administration of Intravenous Tranexamic Acid: A Double-Blind Randomized Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain.
Detailed Description
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain. Patients received the standard arthroscopic ACL reconstruction with a BTB autograft and were randomized to either receiving or not receiving two individual doses of TXA intra-operatively or receive. The goal of the study is to determine and evaluate the effect of intra-operative TXA on post-operative hemarthrosis, pain reduction, and opioid consumption.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACL Reconstruction w/ BTB Autograft + IV TXA
Arm Type
Active Comparator
Arm Description
Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients received two individual doses of intravenous TXA intra-operatively.
Arm Title
ACL Reconstruction w/ BTB Autograft, no IV TXA
Arm Type
No Intervention
Arm Description
Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients did not receive two individual doses of intravenous TXA intra-operatively. Only the consented surgery was performed.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
Primary Outcome Measure Information:
Title
POST-OPERATIVE HEMARTHROSIS
Description
Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration.
Time Frame
Post-operative week 1
Title
POST-OPERATIVE Opioid Consumption
Description
Each patient's opioid consumption was measured by morphine milligram equivalents (MME).
Time Frame
Days 1-7
Title
POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS)
Description
Pain severity, measured by the Visual Analog Scale (VAS): a scale of 1-10, with 1 being the least amount of pain and 10 being the most amount of pain.
Time Frame
Post-operative day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-PATIENTS UNDERGOING AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT
Exclusion Criteria:
Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
Younger than 18 years of age
Any patient considered a vulnerable subject
Have bleeding or clotting disorder
Preoperative anticoagulation therapy
Abnormal coagulation profile
Renal disorder or insufficiency
Sickle cell disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Alaia, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reducing Hemarthrosis in ACL Reconstruction With BTB Autograft by the Administration of Intravenous TXA
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