Reducing Hemarthrosis in ACL Reconstruction With BTB Autograft by the Administration of Intravenous TXA

Phase 4

Completed

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT03631355
• Lead Sponsor: NYU Langone Health

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 Timeline

• Study Start: 2018-06-06
• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-15
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Results First Submitted: 2020-12-21
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-23
• Last Update Submitted: 2021-02-23
• Results First Posted: 2021-02-24
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACL Reconstruction w/ BTB Autograft + IV TXA	Tranexamic Acid	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.

Primary Outcome Measures

Name	Time	Method
POST-OPERATIVE HEMARTHROSIS	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)	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	Days 1-7	Each patient's opioid consumption was measured by morphine milligram equivalents (MME).

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States