Reducing Hemarthrosis in Anterior Cruciate Ligament Reconstruction With BTB Autograft by the Administration of Intravenous Tranexamic Acid: A Double-Blind Randomized Control Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- POST-OPERATIVE HEMARTHROSIS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ACL Reconstruction w/ BTB Autograft + IV TXA
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.
Intervention: Tranexamic Acid (Drug)
Outcomes
Primary Outcomes
POST-OPERATIVE HEMARTHROSIS
Time Frame: Post-operative week 1
Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration.
POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS)
Time Frame: Post-operative day 7
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.
POST-OPERATIVE Opioid Consumption
Time Frame: Days 1-7
Each patient's opioid consumption was measured by morphine milligram equivalents (MME).
Secondary Outcomes
No secondary outcomes reported