Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 68 of 419 for:    TRANEXAMIC ACID

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
Sponsor:
Information provided by (Responsible Party):
Susan Goobie, Boston Children’s Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Adolescent Idiopathic Scoliosis
Interventions Drug: Tranexamic Acid
Drug: Placebo
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Tranexamic Acid
Hide Arm/Group Description

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 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.
Period Title: Overall Study
Started 60 60
Completed 55 56
Not Completed 5 4
Reason Not Completed
Withdrawal by Subject             5             4
Arm/Group Title Placebo Tranexamic Acid Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 55 56 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 56 participants 111 participants
<=18 years
55
 100.0%
56
 100.0%
111
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 56 participants 111 participants
14.7  (1.8) 14.9  (2.0) 14.8  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 56 participants 111 participants
Female
42
  76.4%
46
  82.1%
88
  79.3%
Male
13
  23.6%
10
  17.9%
23
  20.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 56 participants 111 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
   3.6%
2
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   5.5%
3
   5.4%
6
   5.4%
White
43
  78.2%
46
  82.1%
89
  80.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
9
  16.4%
5
   8.9%
14
  12.6%
weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 55 participants 56 participants 111 participants
56.6  (11.9) 55.1  (11.8) 56  (11.8)
American Society of Anesthesiology Physical Status Classification   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 55 participants 56 participants 111 participants
2
(1 to 3)
2
(1 to 3)
2
(1 to 3)
[1]
Measure Description:

The ASA PHYSICAL STATUS CLASSIFICATION SYSTEM scale is 1-6, ASA 1 being the lowest risk and ASA4 being the higher risk as follows ( ASA 5 AND 6 DO NOT APPLY TO THIS POPULATION):

ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes

1.Primary Outcome
Title Perioperative Blood Loss
Hide Description Perioperative blood loss (during operation and for entire hospital admission)
Time Frame perioperarively - during entire hospital admission
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tranexamic Acid
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 55 56
Mean (Standard Deviation)
Unit of Measure: mL
1031  (484) 836  (373)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tranexamic Acid
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 195
Estimation Comments [Not Specified]
Time Frame during entire hospital admission up to seven days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Tranexamic Acid
Hide Arm/Group Description

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 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.
All-Cause Mortality
Placebo Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/56 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/56 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/56 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: susan Goobie, MD, FRCPC
Organization: Boston Children's Hospital
Phone: 6173667737
EMail: susan.goobie@childrens.harvard.edu
Layout table for additonal information
Responsible Party: Susan Goobie, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT01813058     History of Changes
Other Study ID Numbers: IRB-P00003400
First Submitted: February 25, 2013
First Posted: March 18, 2013
Results First Submitted: November 8, 2017
Results First Posted: February 20, 2019
Last Update Posted: February 20, 2019