Tranexamic Acid and Blood Clots in Knee Surgery
Does the Intraoperative Administration of Tranexamic Acid (TXA) Increase the Incidence of Deep Venous Thrombosis in Total Knee Arthroplasty?
1 other identifier
observational
25
1 country
1
Brief Summary
This is an observational trial to estimate the incidence of deep vein thrombosis (DVT) in total knee replacement patients who received an intraoperative dose of tranexamic acid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2017
Shorter than P25 for all trials
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
August 4, 2016
CompletedFirst Posted
Study publicly available on registry
August 15, 2016
CompletedStudy Start
First participant enrolled
May 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2017
CompletedResults Posted
Study results publicly available
May 20, 2019
CompletedMay 20, 2019
February 1, 2019
6 months
August 4, 2016
February 20, 2019
February 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Deep Vein Thrombosis
Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1
One day
Study Arms (1)
Knee replacement patients receiving TXA
Patients who receive tranexamic acid during total knee replacement surgery
Interventions
Intravenous or local administration of TXA, in any dosage
Eligibility Criteria
Patients having total knee replacement at Sandoval Regional Medical Center in Rio Rancho, New Mexico, and who receive an intraoperative dose of tranexamic acid to control surgical bleeding
You may qualify if:
- Adult patients scheduled for total knee arthroplasty at Sandoval Regional Medical Center with an intraoperative dose of tranexamic acid
You may not qualify if:
- Previous deep vein thrombosis or pulmonary embolism episode
- Known coronary artery disease or peripheral vascular disease
- Previously diagnosed hypercoagulable states (e.g. Leiden factor V, antiphospholipid antibody, protein C or S deficiency)
- Pregnancy
- Creatinine clearance less than 30 ml/min
- Non-fluency in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sandoval Regional Medical Center
Rio Rancho, New Mexico, 87144, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David Siegel
- Organization
- University of New Mexico
Study Officials
- PRINCIPAL INVESTIGATOR
David Siegel, MD
University of New Mexico
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 4, 2016
First Posted
August 15, 2016
Study Start
May 16, 2017
Primary Completion
November 8, 2017
Study Completion
November 8, 2017
Last Updated
May 20, 2019
Results First Posted
May 20, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share