Topical Tranexamic Acid in Major Paediatric Spine Deformity Surgery: A Randomized Controlled Trial
Recruiting in Palo Alto (17 mi)
Overseen byFiroz Miyanji, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Waitlist Available
Sponsor: University of British Columbia
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?
Our study will evaluate the use of topical and intravenous (IV) Tranexamic Acid (TXA) in spine surgery. The purpose of TXA is to prevent clotting during surgery to reduce blood loss. When used intravenously, it has been shown to safe, efficacious, and effective in reducing transfusion requirements and blood loss in spine surgeries. We want to evaluate the effect of using TXA topically and intravenously to see if it further reduces blood loss in children undergoing major surgery compared to IV TXA only
Eligibility Criteria
Inclusion Criteria
All participants between ages of 8 and 21 years old
All patients undergoing spinal deformity surgery for which operative time is anticipated to be greater than 3 hours - Operative time will be defined as time from incision to closure
Treatment Details
Interventions
- Tranexamic Acid (Anti-fibrinolytic agent)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Topical and Intravenous TXAExperimental Treatment2 Interventions
Group II: Intravenous TXA onlyActive Control1 Intervention
Tranexamic Acid is already approved in United States, European Union, Canada, Japan, Australia for the following indications:
🇺🇸 Approved in United States as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
🇪🇺 Approved in European Union as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
- Hereditary angioedema
🇨🇦 Approved in Canada as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
🇯🇵 Approved in Japan as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
🇦🇺 Approved in Australia as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
BC Children's HospitalVancouver, Canada
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor