Comparison of the effect of receiving fresh blood or stored blood components on incidence of bleeding and hemodynamic changes in children with congenital heart diseases candidate for surgery
Comparison of the incidence of bleeding and hemodynamic changes after receiving fresh blood or stored blood components during cardiac surgery in children with congenital heart diseases
Design
This study is a non-randomized clinical trial without control group, with parallel groups. Children were divided in to two groups . The first group will receive fresh blood during operation and the second group will receive stored component during operation.
Settings and conduct
Children with congenital heart diseases who are candidate for cardiac surgery in Chamran hospital are divided in to two groups. Children will receive fresh blood or stored blood components during operation, . After operation volume of bleeding and hemodynamic variables are measured and compared between two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1)having acyanotic congenital heart disease, 2)candidate for cardiac surgery ,3)age between 1 month-5 years, 4)parent's willingness
Exclusion criteria :1) sensitivity to Protamine
Intervention groups
The first intervention group: receiving fresh blood during operation
The second intervention group: receiving stored components during operation
Main outcome variables
Bleeding, hemodynamic changes, prognosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171104037209N2
Registration date:2018-03-12, 1396/12/21
Registration timing:prospective
Last update:2018-03-12, 1396/12/21
Update count:0
Registration date
2018-03-12, 1396/12/21
Registrant information
Name
shima khamesipour
Name of organization / entity
Isfahan School of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 32403150
Email address
massoumigh@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of receiving fresh blood or stored blood components on incidence of bleeding and hemodynamic changes in children with congenital heart diseases candidate for surgery
Public title
fresh blood and stored components in children cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having age between 1 month- 5 years
Having indication for cardiac surgery due to acyanotic congenial heart disease
parent's willingness
Exclusion criteria:
Sensitivity to Protamine
Age
From 1 month old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciene
Street address
Isfahan University of Medical Science, Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
IR.MUI.REC.1396.3.974
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 after operation
Timepoint
After operation in Intensive Care Unit
Method of measurement
Measuring drainage volume
2
Description
Mean Arterial Pressure
Timepoint
After artery line insertion, during operation, in Intensive Care Unit
Method of measurement
Using blood pressure machine
3
Description
Hemoglobin level
Timepoint
After artery line insertion, during operation, in Intensive Care Unit
Method of measurement
Spectrophotometer device
4
Description
Hematocrit
Timepoint
After artery line insertion, during operation, in Intensive Care Unit
Method of measurement
Spectrophotometer device
Secondary outcomes
1
Description
mortality
Timepoint
After operation
Method of measurement
observation
Intervention groups
1
Description
Intervention group: Receiving fresh blood during operation
Category
Treatment - Other
2
Description
Intervention group: Receiving stored components during operation
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Gholamreza Massoumi
Street address
Chamran hospital, Moshtagh street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3261 1400
Email
massoumigh@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Massoumi
Street address
Isfahan University of Medical Science, Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
massoumigh@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Athar Zandi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Science, Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Athar.zandi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Masoumi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Chamran hospital, <oshtagh street
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Fax
Email
massoumigh@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Athar Zandi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
دانشگاه علوم پزشکی اصفهان، خیابان هزار جریب
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
athar.zandi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available