Trial Outcomes & Findings for Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery? (NCT NCT01813058)

NCT ID: NCT01813058

Last Updated: 2019-02-20

Results Overview

Perioperative blood loss (during operation and for entire hospital admission)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 120 participants
• Primary outcome timeframe: perioperarively - during entire hospital admission
• Results posted on: 2019-02-20

Participant Flow

Participant milestones

Measure	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. 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.	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. 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.
Overall Study STARTED	60	60
Overall Study COMPLETED	55	56
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Measure	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. 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.	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. 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.
Overall Study Withdrawal by Subject	5	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=55 Participants 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. 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.	Tranexamic Acid n=56 Participants 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. 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.	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	55 Participants n=5 Participants	56 Participants n=7 Participants	111 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	14.7 years STANDARD_DEVIATION 1.8 • n=5 Participants	14.9 years STANDARD_DEVIATION 2.0 • n=7 Participants	14.8 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	46 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	46 Participants n=7 Participants	89 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
weight	56.6 kg STANDARD_DEVIATION 11.9 • n=5 Participants	55.1 kg STANDARD_DEVIATION 11.8 • n=7 Participants	56 kg STANDARD_DEVIATION 11.8 • n=5 Participants
American Society of Anesthesiology Physical Status Classification	2 units on a scale n=5 Participants	2 units on a scale n=7 Participants	2 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: perioperarively - during entire hospital admission

Perioperative blood loss (during operation and for entire hospital admission)

Outcome measures

Measure	Placebo n=55 Participants 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. 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.	Tranexamic Acid n=56 Participants 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. 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.
Perioperative Blood Loss	1031 mL Standard Deviation 484	836 mL Standard Deviation 373

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tranexamic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

susan Goobie, MD, FRCPC

Boston Children's Hospital

Phone: 6173667737

Email: susan.goobie@childrens.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place