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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 4
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 9085 0
State/province [1] 9085 0

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

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 298264 0
Approval date [1] 298264 0
Ethics approval number [1] 298264 0

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

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
Phone 76518 0
Fax 76518 0
Email 76518 0
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
Phone 76519 0
Fax 76519 0
Email 76519 0
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
Phone 76520 0
Fax 76520 0
Email 76520 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary