Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery?

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Adolescent Idiopathic Scoliosis

In brief

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.

Key facts

Study ID

NCT01813058

Run by

Boston Children's Hospital

People needed

120

Starts

2013-01-01

Expected to finish

2016-05-01

Last updated by the study team

2019-02-20

Who can join

Age: 10 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Children and adolescents (age 10-21 yr) for elective Idiopathic scoliosis corrective surgery; posterior repair.

You may not qualify if…

• 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.

Where it is running

• Boston Childrens Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.