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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions
Adolescent Idiopathic Scoliosis
Interventions
DRUG

Tranexamic Acid

"Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to either:~1. placebo i.e. saline 0.9% (intravenous injection)~2. intravenous TXA given as a loading dose over 15 minutes of 50 mg/kg bolus ( within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery."

DRUG

Placebo

"Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to:~1. Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery or~2. TXA as previously described."

Trial Locations (1)

02115

Boston Childrens Hospital, Boston

All Listed Sponsors
lead

Boston Children's Hospital

OTHER

NCT01813058 - Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery? | Biotech Hunter | Biotech Hunter