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A clinical trial comparing the effect of topical and systemic administration of tranexamic acid versus its non-administration on bleeding volume and the need for blood products after cardiac surgery in children with congenital heart disease

Protocol summary

Study aim
To compare the effect of topical and systemic administration of tranexamic acid versus its non-administration on bleeding volume and the need for blood products after cardiac surgery in children with congenital heart disease
Design
A total of 117 patients with congenital heart disease, admitted to Vali-e-Asr Hospital in Birjand, were selected. Using a table of random numbers, the researcher assigned them to three groups, including two experimental groups and one control group, and a code was assigned to each participant.
Settings and conduct
In this double-blind trial, patient recruitment and surgery were performed in Valiasr hospital of Birjand. All patients underwent general anesthesia and surgery with the standard protocol. In the systemic group, after sternotomy, the patient was given 1 milligram per kilogram of tranexamic acid via the cardiopulmonary pump. In the topical group, after hemostasis and before sternotomy incision was closed, 1 milligram per kilogram bodyweight of tranexamic acid was dissolved in 20 mg of normal saline and poured into the pericardial cavity. The control group only received normal saline.
Participants/Inclusion and exclusion criteria
Major inclusion criteria: elective cardiac surgery; congenital heart disease; and age between one month and 15 years. Major exclusion criteria: treatment with anti-coagulants and the presence of hepatic, renal, or respiratory dysfunction.
Intervention groups
There were three groups in this study. They included the systemic group, receiving tranexamic acid systemically; the topical group, receiving tranexamic acid dissolved in normal saline into the pericardial cavity; and the control group, receiving normal saline.
Main outcome variables
Bleeding volume and need for blood products

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170316033099N11
Registration date: 2020-02-19, 1398/11/30
Registration timing: retrospective

Last update: 2020-02-19, 1398/11/30
Update count: 0
Registration date
2020-02-19, 1398/11/30
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
roozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-29, 1397/11/09
Expected recruitment end date
2019-05-30, 1398/03/09
Actual recruitment start date
2019-01-29, 1397/11/09
Actual recruitment end date
2019-05-30, 1398/03/09
Trial completion date
2019-05-30, 1398/03/09
Scientific title
A clinical trial comparing the effect of topical and systemic administration of tranexamic acid versus its non-administration on bleeding volume and the need for blood products after cardiac surgery in children with congenital heart disease
Public title
Topical and systemic administration of tranexamic acid on pediatric cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Congenital heart disease Age between one month and 15 years Elective cardiac surgery Surgery performed by one single surgeon Informed consent form signed by the patient's guardian
Exclusion criteria:
Treatment with anti-coagulants Presence of hepatic, renal, or respiratory dysfunction Low cardiac output Need for re-surgery Postoperative septicemia
Age
From 1 month old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 120
Actual sample size reached: 117
Randomization (investigator's opinion)
Randomized
Randomization description
After the patients were enrolled, they were allocated to one of the three study groups using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the surgeon were blinded as to which study group the patient was allocated.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2019-01-28, 1397/11/08
Ethics committee reference number
ir.bums.REC.1397.322

Health conditions studied

1

Description of health condition studied
congenital heart disease
ICD-10 code
Q24.9
ICD-10 code description
Congenital malformation of heart, unspecified

Primary outcomes

1

Description
bleeding volume
Timepoint
From the completion of the surgery up to 48 hours after surgery
Method of measurement
Measurement of chest drainage volume in the chest tube

2

Description
Need for blood products including packed red blood cells, fresh frozen plasma, and platelets
Timepoint
From the completion of the surgery up to 48 hours after surgery
Method of measurement
Measurement of the packs in terms of cc

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1 (systemic): After sternotomy, the patient was given 1 milligram per kilogram of tranexamic acid via the cardiopulmonary pump. Subsequently, the patient was prescribed heparin so that the activated clotting time would pass 450 seconds. At the end of the operation, after the patient was discharged from the cardiopulmonary pump, heparin was neutralized upon the administration of protamine sulfate at a dose of one mg per 100 units of heparin. Afterward, one milligram per kilogram of tranexamic acid was re-administered.
Category
Prevention

2

Description
Intervention group 2 (topical): After hemostasis and before sternotomy incision was closed, 1 milligram per kilogram bodyweight of tranexamic acid was dissolved in 20 mg of normal saline and poured into the pericardial cavity.
Category
Prevention

3

Description
Control group: They received normal saline only.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Mahmood Hosseinzadeh Maleki
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3242 5402
Email
HoseinzadehMalekiM@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Farbod Hatami
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5632
Email
Farbod_2006_123@yahoo.ca

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahmood Hosseinzadeh Maleki
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Imam Reza Hospital, Ibn Sina Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
00985131908
Email
HoseinzadehMalekiM@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari St.,
City
Birjand,
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Fax
+98 56 3242 0447
Email
roozgar@bums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set
When the data will become available and for how long
After the article extracted from the research project is published online or in print and for six months
To whom data/document is available
Readers of the article
Under which criteria data/document could be used
research purposes
From where data/document is obtainable
Personal correspondence via email to the corresponding author
What processes are involved for a request to access data/document
email to the corresponding author
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