Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
1 other identifier
interventional
100
1 country
2
Brief Summary
Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often underestimated. However there has been growing emphasis on identification of these injuries and practice patterns.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2018
Shorter than P25 for phase_4
2 active sites
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
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 28, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedResults Posted
Study results publicly available
April 29, 2020
CompletedApril 29, 2020
April 1, 2020
10 months
August 28, 2018
December 31, 2019
April 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Estimated Blood Loss
Total estimated blood loss in millilitres during the surgery
Average intra operative time 1-2 hours
Secondary Outcomes (3)
Number of Participants With Wound Complications
at first post-operative visit, 2 weeks post surgery
Intra Operative Narcotic Consumption
Average intra operative time 1-2 hours
Post Operative Narcotic Consumption
2 weeks after surgery
Study Arms (2)
Tranexamic acid group
ACTIVE COMPARATOR10mg/kg intravenous tranexamic
Normal Saline group
PLACEBO COMPARATOR10mg/kg intravenous normal saline
Interventions
Eligibility Criteria
You may qualify if:
- ASA (American Society of Anesthesiology) class I-IV
- age 8-75.
You may not qualify if:
- ASA class V
- morbid obesity
- patient refusal
- patients with known coagulopathy disorder
- renal insufficiency
- hepatic dysfunction
- serious cardiac disease
- an allergy to TXA or receiving antiplatelet and /or anticoagulant drugs will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Ichan School of Medicine
New York, New York, 10029, United States
Related Publications (1)
Xie B, Tian J, Zhou DP. Administration of Tranexamic Acid Reduces Postoperative Blood Loss in Calcaneal Fractures: A Randomized Controlled Trial. J Foot Ankle Surg. 2015 Nov-Dec;54(6):1106-10. doi: 10.1053/j.jfas.2015.07.006. Epub 2015 Aug 24.
PMID: 26310621BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Poonam Pai B. H
- Organization
- Icahn School of Medicine at Mount Sinai
Study Officials
- PRINCIPAL INVESTIGATOR
Ettore Vulcano, MD
Ichan School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 28, 2018
First Posted
August 31, 2018
Study Start
March 1, 2018
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
April 29, 2020
Results First Posted
April 29, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share