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Trial registered on ANZCTR


Registration number
ACTRN12617001176358
Ethics application status
Approved
Date submitted
24/07/2017
Date registered
10/08/2017
Date last updated
10/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison between infusion and bolus of Tranexamic acid to reduce bleeding in Cyanotic congenital heart disease surgeries.
Scientific title
Comparison between Intravenous Boluses versus Infusion of Tranexamic Acid (TXA) to Reduce Bleeding In Paediatric Cyanotic CHD Surgeries; A Randomized Clinical Control Trial.
Secondary ID [1] 292515 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cyanotic congenital heart disease 304157 0
Condition category
Condition code
Cardiovascular 303488 303488 0 0
Other cardiovascular diseases
Anaesthesiology 303605 303605 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tranexamic acid Infusion (considered as intervention) - intravenous infusion at 5 mg/kg/hour started induction and continued throughout surgery and ICU stay till post-operative bleeding drops to less than 0.5-1 ml/kg/hour.
Intervention code [1] 298698 0
Treatment: Drugs
Comparator / control treatment
Tranexamic acid bolus (considered as control group) - intravenous administration of 10 mg/kg boluses at induction, going on CPB and After protamine reversal in 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 302857 0
Post-operative bleeding in ml/kg, assessed by reviewing medical records.
Timepoint [1] 302857 0
1st 24 hours after surgery
Primary outcome [2] 302858 0
Chest closure time in minutes assessed from completion of protamine infusion to approximation of chest by tightening of sternal wires using Stop watch.
Timepoint [2] 302858 0
in OR
Secondary outcome [1] 337256 0
usage of RBCs (Red pack cell), assessed by reviewing medical record.
Timepoint [1] 337256 0
in Operating room and in 1st 24 hours in CICU after surgery
Secondary outcome [2] 337559 0
usage of Platelets, assessed by reviewing medical record
Timepoint [2] 337559 0
in Operating room and 1st 24 hours in CICU after surgery
Secondary outcome [3] 337560 0
usage of FFPs, assessed by reviewing medical records
Timepoint [3] 337560 0
in Operating room and 1st 24 hours in CICU after surgery
Secondary outcome [4] 337561 0
usage of Cryoprecipitate, assessed by reviewing medical records
Timepoint [4] 337561 0
in Operating room and 1st 24 hours in CICU after surgery
Secondary outcome [5] 337562 0
usage of Whole blood, assessed by reviewing medical records
Timepoint [5] 337562 0
in Operating room and 1st 24 hours in CICU after surgery

Eligibility
Key inclusion criteria
• Age group: Neonates to 16 yrs.
• Cyanotic Congenital heart surgery.
• Use of cardiopulmonary bypass.
• First open heart surgery
Minimum age
1 Days
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Renal dysfunction (Serum creatinine >1.5 mg/dl)
• Previous neurological event
• Congenital or Acquired bleeding disorder (INR>1.5, H/O Easy bruisebility)
• Allergic to tranexamic acid (1ml=50mg test dose to test allergy).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computer software (using software PASS, ver. 11.04 by randomization algorithm)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was based on a previous study (Chauhan S, Bisoi A, Kumar N, et al. Dose comparison of tranexamic acid in pediatric cardiac surgery. Asian Cardiovascular and Thoracic Annals. 2004; 12: 121-24) in which the postoperative mean blood loss for the first 24 hours of the patients in boluses group was 20±13 ml/kg. A 35% difference in the mean blood loss of (i.e.13±5) ml/kg between the Tranexamic infusion and boluses groups was suggested to be considered significant. A sample size of 27 subjects in each group was considered sufficient to detect a 35% difference in blood loss with a power of 0.8 and type I error of 0.05. It was assumed that the study dropout rate would be 10% and therefore a total of 60 patients (30 in each group) were recruited.
All statistical analyses were performed using Statistical Packages for Social Science version 19 (SPSS Inc., Chicago, IL). Normality of age, weight, height, Time to chest closure and postoperative bleeding was checked by kolmorov-smirnve test then applied student t-test and for non-normal data Mann-Whitney test used to compare mean (SD) difference between groups. Frequency and percentage was computed for gender. P = 0.05 was considered as significant. GLM Univariate analysis procedure (instead of stratification) was used to control confounder like age, height, weight and gender to observed effect on outcomes. P = 0.05 was considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/07/2016
Date of last participant enrolment
Anticipated
Actual
3/04/2017
Date of last data collection
Anticipated
Actual
4/04/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 9085 0
Pakistan
State/province [1] 9085 0
Sind

Funding & Sponsors
Funding source category [1] 297086 0
Hospital
Name [1] 297086 0
Aga Khan University hospital
Country [1] 297086 0
Pakistan
Primary sponsor type
Individual
Name
Irfan Akhter
Address
Department of anaesthesiology Aga khan university hospital, stadium road karachi , PO box 3500, postcode 74800
Country
Pakistan
Secondary sponsor category [1] 296093 0
Individual
Name [1] 296093 0
Faisal junejo
Address [1] 296093 0
Department of anaesthesiology Aga khan university hospital, stadium road karachi , PO box 3500, postcode 74800
Country [1] 296093 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298264 0
Ethics review commitee Aga khan university
Ethics committee address [1] 298264 0
Ethics review committee, Aga khan university hospital Karachi , stadium road Karachi PO box 3500, postcode 74800.
Ethics committee country [1] 298264 0
Pakistan
Date submitted for ethics approval [1] 298264 0
04/05/2016
Approval date [1] 298264 0
12/07/2016
Ethics approval number [1] 298264 0
4260-Ane-ERC-16

Summary
Brief summary
Excessive bleeding in both adults and paediatric cardiac surgery increases morbidity and mortality. Paediatric patients undergoing cardiac surgery are at high risk for intraoperative and postoperative bleeding.Increased bleeding in children exposes them to transfusion of blood and blood products, hence increased risk of complications associated with transfusion.
Tranexamic acid is being used to reduce bleeding but there is no specific dose or regimen. We compared two different regimens of Tranexamic acid i.e infusion and bolus to see which is better in terms of Post-operative bleeding, chest closure time and blood products usage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76518 0
Dr Faisal Junejo
Address 76518 0
Department of Anaesthesiology Aga khan university hospital, stadium road Karachi , PO box 3500, postcode 74800
Country 76518 0
Pakistan
Phone 76518 0
+92-21-3486-4631
Fax 76518 0
+92-21-3493-4294
Email 76518 0
[email protected]
Contact person for public queries
Name 76519 0
Dr Faisal Junejo
Address 76519 0
Department of Anaesthesiology Aga khan university hospital, stadium road karachi , PO box 3500, postcode 74800.
Country 76519 0
Pakistan
Phone 76519 0
+92-21-3486-4631
Fax 76519 0
+92-21-3493-4294
Email 76519 0
[email protected]
Contact person for scientific queries
Name 76520 0
Dr Irfan Akhter
Address 76520 0
Anaesthesia department Aga khan university hospital Karachi, stadium road karachi, PO box 3500, postcode 74800
Country 76520 0
Pakistan
Phone 76520 0
+92-21-3486-4631
Fax 76520 0
+92-21-3493-4294
Email 76520 0
[email protected]

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