Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000045314
Ethics application status
Approved
Date submitted
15/11/2016
Date registered
10/01/2017
Date last updated
10/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical evident and laboratory investigations of efficacy of three doses of
tranexamic acid to avoid fibrinolysis in pediatric cardiac surgery.
Scientific title
Selection of appropriate tranexamic acid dose to prevent fibrinolysis in pediatric cardiac surgery
Secondary ID [1] 290548 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pediatric cardiac surgery for congenital heart disease 300990 0
Condition category
Condition code
Cardiovascular 300786 300786 0 0
Other cardiovascular diseases
Blood 300967 300967 0 0
Normal development and function of platelets and erythrocytes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be divided into three groups according to age: group(A) 0-2 months ,group (B) 2 to 12 months, group(c) more than 12 months but less than 20 kg. Each group will be divided into three groups according to the tranexamic acid dose.
Group (A) will be divided into three subgroups:
A1( low dose group): loading dose given as intravenous bolus 15 mg/kg with induction of anesthesia before skin incision. Intravenous infusion dose given 2.5 mg/kg/hr will be started after the loading dose and stopped by end of skin closure. priming fluid 20ug/ml tranexamic acid added to the priming fluid.
A2 ( Intermediate dose group): intravenous loading dose 50 mg/kg given with induction of anesthesia. Intravenous infusion dose: 7 mg/kg/hr started after loading dose and given through the whole procedure will be stopped by the end of skin closure. priming fluid 60ug/ml.
A3 ( high dose group): intravenous loading dose: 100 mg/kg with induction of anesthesia before skin incision. Intravenous infusion dose will be given with anesthesia induction before skin incision 10 mg/kg/hr given through the procedure and stopped by end of skin closure. priming fluid 100ug/ ml
Group (B) will be divided in three groups:
B1 ( low dose group): intravenous loading dose 9 mg/kg given with induction of anesthesia before skin incision . Intravenous infusion dose: 2 mg/kg/hr given through the procedure and will be stopped by end of skin closure. priming fluid 20 ug/ml.
B2 ( intermediate dose): intravenous loading dose 26 mg/kg given with induction of anesthesia before skin incision. Intravenous infusion dose 6 mg/kg/hr given through the procedure and to be stopped by end of skin closure. priming fluid 60 ug/ml.
B3 (high dose): intravenous loading dose 65mg/kg given with induction of anesthesia before skin incision . Intravenous infusion dose 14 mg/kg/hr given through the whole procedure and to be stopped by end of skin closure. priming fluid 150ug/ml.
Group c will be divided in three subgroups
C1 ( low dose): intravenous loading dose 4 mg/kg given with induction of anesthesia before skin incision . Intravenous infusion dose 2mg/kg/hr given through the whole procedure and to be stopped by end of skin closure. priming fluid 20ug/ml
C2 ( Intermediate dose): intravenous loading dose 13 mg/kg given with induction of anesthesia before skin incision. intravenous infusion dose: 5.5 mg/kg/hr given through the whole procedure and to be stopped by end of skin closure. priming fluid 60ug/ml.
C3 ( high dose): intravenous loading dose: 31 mg/kg given with induction of anesthesia before skin incision. Intravenous Infusion dose: 14 mg/kg/hr given through the whole procedure and to be stopped by end of skin closure. priming fluid 100 ug/ml.
Designated control laboratory tests are thromboelestometry machine and D-dimer will be measured 3 times:
First sample just after induction of anesthesia and after tranexamic loading dose.
Second measurement 15 minutes after start of cardiopulmonary bypass with ongoing tranexamic acid infusion dose.
Third measurement 5 minute after protamine full dose given post bypass.
Intervention code [1] 296411 0
Treatment: Drugs
Comparator / control treatment
It is comparisson between three groups receiving low, intermediate and high dose of tranexamic acid. in relation to three age groups undergoing pediatric cardiac surgery 0-2 months, 2-12 months and more than 12 months.
Control group
Dose comparison

Outcomes
Primary outcome [1] 300393 0
D Dimer testing intraoperative
Timepoint [1] 300393 0
three times after loading dose of tranexamic acid, after starting cardiopulmonary bypass by 15 minutes and last time 5 minutes after protamine full dose by the end of the bypass.
Primary outcome [2] 300394 0
thromboelestometry machine testing
Timepoint [2] 300394 0
Three times after loading dose of tranexamic acid, after starting cardiopulmonary bypass by 15 minutes and last time 5 minutes after protamine full dose by the end of the bypass.
Primary outcome [3] 300395 0
calculation of the first 24 hours total chest tube drainage.
Timepoint [3] 300395 0
in the cardiothoracic ICU during the first 24 hours postoperative.
Secondary outcome [1] 329340 0
The requirement of blood products introperative and postoperative in the first 24 hours. by review the system sheet of the first 24 hours drainage calculated by the ICU nurse.
Timepoint [1] 329340 0
first 24 hours in postoperative intensive care unit

Eligibility
Key inclusion criteria
Three groups of pediatric patients undergoing cardiac surgery divided into three groups according to their age 0-2 months and 2-12 months and more than 12 months.
Minimum age
No limit
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Renal failure patients
2) Liver cell failure
3) Patients suffering coagulopathy
4) Patients on anticoagulants medications.
5) Emergency cases.
6) Seizures.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
non-randomization process, patients were assigned to one of the study groups by the anesthetist consultant in the room he has the choice to select which group of medication suits this age group.
Statistical analysis was done on a personal computer using the IBM SPSS Statistics version 21 (IBM Corp., Armonk, NY). Categorical data were presented as ratio or as number and percentage and between-group differences were compared using the Pearson chi square test or the chi square test for trends for nominal or ordinal data, respectively. Data gathering from patient laboratory tests on his flowsheet on ICIS system of the hospital, and total 24 hours drainage from patient ICU chart on the first 24 hours postoperative

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 8391 0
Saudi Arabia
State/province [1] 8391 0
jeddah

Funding & Sponsors
Funding source category [1] 294976 0
Hospital
Name [1] 294976 0
king faisal specialist hospital and research centre
Country [1] 294976 0
Saudi Arabia
Primary sponsor type
Hospital
Name
king faisal specialized hospital and research centre
Address
price sultan road , alkhaldia district , jeddah, saudi arabia
Country
Saudi Arabia
Secondary sponsor category [1] 293797 0
None
Name [1] 293797 0
Address [1] 293797 0
Country [1] 293797 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296334 0
king faisal research centre
Ethics committee address [1] 296334 0
prince Saud Alfaisal street, Alkhaldia, jeddah, saudia arabia.
Ethics committee country [1] 296334 0
Saudi Arabia
Date submitted for ethics approval [1] 296334 0
22/09/2016
Approval date [1] 296334 0
06/11/2016
Ethics approval number [1] 296334 0

Summary
Brief summary
Tranexamic acid inhibits fibrinolysis and decreases bleeding in surgical patients especially in cardiac surgeries. There is no consensus over its dose. Different centers use different doses during cardiac surgeries. Even in the same hospital different physicians give different doses of tranexamic acid during adult and pediatric cardiac surgeries. Recently, a pharmacokinetic model has been made by Wesley et al that has depicted three different doses to achieve the optimum plasma level. These doses have not been validated clinically or by the laboratory tests to find the optimum dose that inhibits fibrinolysis and decreases bleeding. We would like to find out the optimum dose of tranexamic acid by using the doses of the Wesley’s pharmacokinetics model. We will measure the extent of fibrinolysis done by these doses through clinical observations and laboratory tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70498 0
Dr Mostafa kamal Abdellatif Asr
Address 70498 0
king faisal specialized hospital and research centre, jeddah. saudi arabia
Country 70498 0
Saudi Arabia
Phone 70498 0
+96665504487096
Fax 70498 0
Email 70498 0
mostafa_2041980@yahoo.com
Contact person for public queries
Name 70499 0
Dr Mostafa kamal Abdellatif Asr
Address 70499 0
king faisal specialized hospital and research centre, jeddah. saudi arabia
Country 70499 0
Saudi Arabia
Phone 70499 0
+966542057620
Fax 70499 0
Email 70499 0
mostafa_2041980@yahoo.com
Contact person for scientific queries
Name 70500 0
Dr Mostafa kamal Abdellatif Asr
Address 70500 0
king faisal specialized hospital and research centre, jeddah. saudi arabia
Country 70500 0
Saudi Arabia
Phone 70500 0
+96665504487096
Fax 70500 0
Email 70500 0
mostafa_2041980@yahoo.com

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No Supporting Document Provided



Results publications and other study-related documents

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