Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01813058|
Recruitment Status : Completed
First Posted : March 18, 2013
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Idiopathic Scoliosis||Drug: Tranexamic Acid Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy of Intravenous Tranexamic Acid in Decreasing Blood Loss in Pediatric Idiopathic Scoliosis Surgery?|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Placebo Comparator: Placebo
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.
Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to:
Other Name: 0.9% Normal saline
Active Comparator: Tranexamic acid
Tranexamic acid 100 mg/ml; 50 mg/kg loading dose = 0.5 ml/kg LD given over 15 minutes and 10 mg/kg/hr = 0.1 ml/kg/hr infusion for the duration of the surgery.
Drug: Tranexamic Acid
Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to either:
Other Name: Cyklokapron, TXA, TA
- Perioperative Blood Loss [ Time Frame: perioperarively - during entire hospital admission ]Perioperative blood loss (during operation and for entire hospital admission)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813058
|United States, Massachusetts|
|Boston Childrens Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Susan Goobie, MD, FRCPC||Boston Children’s Hospital|