Skip to main content
OpenTrials
Completed

NCT Number: NCT03631355

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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

Primary outcomes

  1. 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.

  2. POST-OPERATIVE Opioid Consumption

    Time frame: Days 1-7

    Each patient's opioid consumption was measured by morphine milligram equivalents (MME).

  3. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Reducing Hemarthrosis in Anterior Cruciate Ligament Reconstruction With BTB Autograft by the Administration of Intravenous Tranexamic Acid: A Double-Blind Randomized Control Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2018
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.