Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
1 other identifier
interventional
58
1 country
1
Brief Summary
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing high tibial osteotomy (HTO) and tibial tubercle osteotomy (TTO) to minimize hemarthrosis within the knee joint and post operative pain and swelling.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2018
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2018
CompletedStudy Start
First participant enrolled
June 26, 2018
CompletedFirst Posted
Study publicly available on registry
July 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2021
CompletedResults Posted
Study results publicly available
September 21, 2022
CompletedSeptember 21, 2022
August 1, 2022
2.9 years
May 22, 2018
August 5, 2022
August 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perioperative Blood Loss
Perioperative, up to 2 hours
Secondary Outcomes (3)
Score on Visual Analogue Scale (VAS) for Pain
Day 1
Score on Visual Analogue Scale (VAS) for Pain
Day 4
Score on Visual Analogue Scale (VAS) for Pain
Day 7
Study Arms (2)
High Tibial Osteotomy (HTO)
ACTIVE COMPARATORTibial Tubercle Ostetomy (TTO)
ACTIVE COMPARATORInterventions
One gram of intravenous tranexamic acid (TXA) will be administrated before tourniquet inflation and before closure of the incision, as 1 g has been shown to be a safe amount with minimal side effects
Eligibility Criteria
You may qualify if:
- Patients undergoing TTO
- Age 18-60
- Willing and able to provide consent
You may not qualify if:
- Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
- Younger than 18 years of age
- Older than 60 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael J. Alaia, MD
- Organization
- NYU Langone Health
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Alaia, MD
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
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
May 22, 2018
First Posted
July 30, 2018
Study Start
June 26, 2018
Primary Completion
June 2, 2021
Study Completion
June 2, 2021
Last Updated
September 21, 2022
Results First Posted
September 21, 2022
Record last verified: 2022-08