Effect of fresh frozen plasma for priming cardiopulmonary bypass machine on rotational thromboelastometry (Rotem) parameters and received blood products in children undergoing cardiac surgery
The aim of the study is to examine the effect of fresh frozen plasma (FFP) for priming cardiopulmonary bypass machine on rotationa thromboelastometry (Rotem) parameters and received blood products in children undergoing cardiac surgery. In this randomized controlled trial, children undergoing open heart surgery will be randomely allocated to experimental or control group. Inclusion criteria will be negative history of sternotomy, coagulopathy and liver dysfunction. Exclusion criteria will include patients death, giving up the cooperation by patient or the family and receiving blood products during the last 24 hrs. In the experimental group, FFP and crystalloid solution (Ringer) and in the control group, Hydroxyethyl Starch and crystalloid solution (Ringer) will be used as priming solution for cardiopulmonary bypass pump. Rotem parameters will be measured two times, before anesthesia induction and 10 minutes after protamine injection. Rotem parameters and the volume of received blood products will be compared between the groups using statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101313785N3
Registration date:2016-12-30, 1395/10/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-30, 1395/10/10
Registrant information
Name
Hamid Peyrovi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4404
Email address
h-peyrovi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-01-04, 1395/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fresh frozen plasma for priming cardiopulmonary bypass machine on rotational thromboelastometry (Rotem) parameters and received blood products in children undergoing cardiac surgery
Public title
The effect of fresh frozen plasma on rotational thromboelastometry (Rotem) parameters and received blood products in children under cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: No history of sternotomy; No coagulopathy; No hepatic diasese
Exclusion Criteria: Dying patient; Giving up participation in the study; blood or blood products transfusion within the last 24 hrs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random allocation by random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Sheikhfazlollah and Hemmat expertways crossover
City
Tehran
Postal code
Approval date
2016-03-07, 1394/12/17
Ethics committee reference number
IR.IUMS.REC 1394.9211584202
Health conditions studied
1
Description of health condition studied
Cardiovascular Disease
ICD-10 code
Q28-9
ICD-10 code description
Congenital malformation of circulatory system, unspecified
Primary outcomes
1
Description
Rotem parameters
Timepoint
before anesthesia induction and after weaning from cardiopulmonary bypass machine
Method of measurement
Rotem measurement system
Secondary outcomes
1
Description
Received boold products
Timepoint
during operation and 24hrs after surgery
Method of measurement
Milliliter
Intervention groups
1
Description
Intervention group: ّor every kg of body weight, 10-20 ml fresh frozen plasma (FFP) and 100-200 ml crystalloid solution (Ringer dolurion) will be used as priming solution. To maintain hematocrit at 20 percent, all patients will receive packed cell. remaining of the cardiovascular bypass process would be the same for both groups. After surgery, to alleviate the effect of heparin, 1 mg Protamin/ kg body weight will be injected and then the patient will be weaned from bypass machine.
Category
Prevention
2
Description
Control group: For every kg of body weight, 10-20 ml hydroxyethyl starch with proportion of 130 to 0.4 and 100-200 ml crystalloid solution (Ringer dolurion) will be used as priming solution. To maintain hematocrit at 20 percent, all patients will receive packed cell. Remaining of the cardiovascular bypass process would be the same for both groups. After surgery, to alleviate the effect of heparin, 1 mg Protamin/ kg body weight will be injected and then the patient will be weaned from bypass machine.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaei Cardiovascular, Medical and Research Center
Full name of responsible person
Dr. Hamid Peyrovi
Street address
School of Nursing and Midwifery, Rashid Yasami St., Vali-Asr Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of research of Iran University of Medical Sciences
Full name of responsible person
Dr. Naserbakht
Street address
Research director of Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of research of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hamid Peyrovi
Position
Ph.D in Nursing, Faculty member
Other areas of specialty/work
Street address
Vali-Asr Ave, After Vanak Sq, Rashidyasami St., school of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 4365 1705
Fax
Email
hamidpeyravi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hamid Peyrovi
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Vali-Asr Ave, After Vanak Sq, Rashidyasami St., school of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 4365 1705
Fax
Email
hamidpeyravi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Dr. Hamid Peyrovi
Position
PhD of Nursing/ faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rashid Yasami St., Vali-Asr Ave.
City
Tehran
Postal code
Phone
+98 21 4365 1705
Fax
Email
hamidpeyravi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)