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

Anterior Cruciate Ligament Reconstruction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631355
• Other study ID #: 18-00538
• Status: Completed
• Phase: Phase 4
• Start date: June 6, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: February 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction
• Hemarthrosis

Intervention

Drug:
• Tranexamic Acid
One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POST-OPERATIVE HEMARTHROSIS	Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration.	Post-operative week 1
Primary	POST-OPERATIVE Opioid Consumption	Each patient's opioid consumption was measured by morphine milligram equivalents (MME).	Days 1-7
Primary	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.	Post-operative day 7