Phase 4
N=110
Reducing Hemarthrosis in ACL Reconstruction With BTB Autograft by the Administration of Intravenous TXA
Anterior Cruciate Ligament Reconstruction
Bottom Line
View on ClinicalTrials.gov: NCT03631355 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: POST-OPERATIVE HEMARTHROSIS — 26.7; 37.3 ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic Acid (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY POST-OPERATIVE HEMARTHROSIS |
26.7; 37.3 | — |
| PRIMARY POST-OPERATIVE Opioid Consumption |
130.9; 113.9 | — |
| PRIMARY POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS) |
2.7; 3.2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03631355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.