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

NYU Langone Health

Status and phase: Completed; Phase 4

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03631355

18-00538

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

ACL Reconstruction w/ BTB Autograft + IV TXA

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid

ACL Reconstruction w/ BTB Autograft, no IV TXA

No Intervention group

Description:

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.