Overview

Topical Tranexamic Acid in Major Paediatric Spine Deformity Surgery: A Randomized Controlled Trial

Status:
Unknown status
Trial end date:
2017-02-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of British Columbia
Treatments:
Tranexamic Acid
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

Exclusion Criteria:

- 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

- Planned staged procedures and procedures with less than 50 cc of blood loss not
considered reason for study exclusion - Eg. change of negative pressure wound
dressing, tracheostomy, central-line placement

- Inability of patient or legal guardian to provide study consent