Status:
COMPLETED
Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery?
Lead Sponsor:
Boston Children's Hospital
Conditions:
Adolescent Idiopathic Scoliosis
Eligibility:
All Genders
10-21 years
Phase:
PHASE1
PHASE2
Brief 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 antifibrino...
Detailed Description
This prospective randomized double-blinded study will enroll 120 children and adolescents ages undergoing scoliosis repair with the diagnosis of idiopathic scoliosis. The primary aim is to determine i...
Eligibility Criteria
Inclusion
- Children and adolescents (age 10-21 yr) for elective Idiopathic scoliosis corrective surgery; posterior repair.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01813058
Start Date
January 1 2013
End Date
May 1 2016
Last Update
February 20 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115