Tranexamic Acid in Major Orthopedic Surgery: Comparison of 3 Dosage Regimen
1 other identifier
observational
210
0 countries
N/A
Brief Summary
Tranexamic acid has been shown to be effective in reducing blood loss and transfusion in orthopedic surgery. It remains unknown the ideal therapeutic regimen. The goal of this study is to compare 3 dosage regimen of tranexamic acid in patients submitted to major orthopedic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Shorter than P25 for all trials
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
June 7, 2018
CompletedFirst Posted
Study publicly available on registry
June 29, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJune 29, 2018
June 1, 2018
9 months
June 7, 2018
June 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Perioperative bleeding
perioperative blood loss measured in mililiters (mL)
postoperative day 2
Study Arms (3)
intra-op single dose
intra-operative single dose of tranexamic acid
intra-op dose and additional dose
intra-operative dose of tranexamic acid and additional dose 3 hours after
intra-op dose and perfusion
intra-operative dose of tranexamic acid followed by a continuous infusion during 6 hours.
Interventions
Tranexamic acid effect on perioperative bleeding in orthopedic surgery
Eligibility Criteria
• Patients of a median size private hospital in Portugal
You may qualify if:
- Age ≥ 18 anos
- Total ankle arthroplasty
- Total knee arthroplasty
- Weight \>50 kilogram
You may not qualify if:
- Allergy and Hypersensitivity to tranexamic acid
- Thromboembolic events history
- Epilepsy
- Acute kidney injury, Glomerular Filtration Rate \< 50 ml/min
- Coagulation disorders
- Surgical reintervention
- Blood transfusion refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela Sa, MD
CUF Santarem Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 7, 2018
First Posted
June 29, 2018
Study Start
July 1, 2018
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
June 29, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share