Topical Tranexamic Acid in Major Paediatric Spine Deformity Surgery: A Randomized Controlled Trial
1 other identifier
interventional
160
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2015
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
March 18, 2014
CompletedFirst Posted
Study publicly available on registry
March 21, 2014
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedDecember 2, 2015
November 1, 2015
1.5 years
March 18, 2014
November 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Volume of Blood Loss
Intra-operative
Secondary Outcomes (1)
Complications (reporting)
6 week visit
Study Arms (2)
Topical and Intravenous TXA
EXPERIMENTALIntravenous TXA only
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Violation of the dura intraoperatively
- Requirement of therapeutic anticoagulation in the perioperative period
- Baseline coagulation disorder
- History of thromboembolic event, including, but not limited to:
- Myocardial infarction within past 6 months
- Deep vein thrombosis
- Pulmonary embolus
- Cerebrovascular accident or transient ischemic event
- Retinal artery occlusion
- Renal impairment - eGFR \< 60 mL/min/1.73m2
- Pregnant
- Allergy to tranexamic acid
- Additional surgical procedures or interventions within the 7 days prior to the index spinal surgery, or within 72h following the index spinal surgery
- Inability of patient or legal guardian to provide study consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
Study Officials
- STUDY CHAIR
Brett Kilb, Md
Resident
- PRINCIPAL INVESTIGATOR
Firoz Miyanji, MD
Clinical Assistant Professor
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2014
First Posted
March 21, 2014
Study Start
August 1, 2015
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
December 2, 2015
Record last verified: 2015-11