Phase 2
N=120
Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery?
Adolescent Idiopathic Scoliosis
Bottom Line
View on ClinicalTrials.gov: NCT01813058 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Perioperative Blood Loss — 1031; 836 mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tranexamic Acid (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perioperative Blood Loss |
1031; 836 | <0.001 sig |
Summary
Adolescent idiopathic scoliosis surgery is an extensive procedure associated with significant blood loss frequently requiring the transfusion of blood. Tranexamic acid (TXA) is a synthetic antifibrinolytic (prevents breakdown of the blood clot) that has been used to extensively reduce transfusion in pediatric major surgery, including cardiac, craniofacial and orthopedic surgery. In this prospective randomized double-blinded study, the investigators wish to evaluate the hypothesis that TXA is more effective than standard of care at decreasing blood loss and blood transfusion perioperatively in children and adolescents undergoing idiopathic scoliosis surgery.
Eligibility Criteria
Inclusion Criteria
- Children and adolescents (age 10-21 yr) for elective Idiopathic scoliosis corrective surgery; posterior repair.
Exclusion Criteria
- Preexisting coagulopathy, (INR>1.4, PTT>1.4xN, PT>1.4xN, platelet count<150,000/mm3), severe hematological disorders, hepatic failure, or renal failure. Ingestion of acetylsalicylate within 14 days or NSAIDs within 2 days of the scheduled surgery date; history of prior blood transfusion. Pre-donation of autologous blood. Patients having anterior-posterior repair.
Data sourced from ClinicalTrials.gov (NCT01813058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.