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

NCT03631355 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 18-00538
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (3)

• 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

• POST-OPERATIVE Opioid Consumption

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

  Days 1-7

• 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

Study Arms (2)

ACL Reconstruction w/ BTB Autograft + IV TXA

ACTIVE COMPARATOR

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.

Drug: Tranexamic Acid

ACL Reconstruction w/ BTB Autograft, no IV TXA

NO INTERVENTION

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.

Interventions

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.

ACL Reconstruction w/ BTB Autograft + IV TXA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PATIENTS UNDERGOING AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

Possibility of observer bias is present as we did not perform in-office aspirations in patients in whom we thought the hemarthroses were not clinically significant, as these procedures can be painful and confer some risk of infection. Despite the decision to aspirate being made clinically, post-study analysis revealed no difference in the rate each surgeon performed an aspiration.

Results Point of Contact

• Title: Dr. Michael J. Alaia
• Organization: NYU Langone Health Orthopedic Hospital

michael.alaia@nyulangone.org

6465017223

Study Officials

• Michael Alaia, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 15, 2018
• Study Start: June 6, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: February 24, 2021
• Results First Posted: February 24, 2021

Record last verified: 2021-02

Locations

US (1)