This study is a randomized clinical trial in which the effect of autologous priming technique in patient that undergoing coronary artery bypass grafting by cardiopulmonary bypass machine will be examined. Patient who entered the study are the first and non emergency coronary surgery and age between 18 to 70 years old; hemoglobin between 8.5 to 14; weight between 45 to 100 kilogram and ejection fraction greater than 25 percent. If they have emergency surgery; have liver dysfunction; dialysis be; being connected to mechanical ventilation; have clotting problem, hemofilter and cell saver are used are excluded from study. Patient who have inclusion criteria randomly divided into two groups, intervention(40 person) and control (40 person). In people who are enrolled before and after cardiopulmonary bypass venous and arterial cannulation 300-600 ml of crystalloid fluid that is used to prime the bypass circuits of the arterial and venous out of orbit and is replaced with the patient's own blood. The result of this work on blood gas and hemoglobin and hematocrit in the operating room and the ward and its impact on the need for blood transfusions and blood products and ejection fraction of heart and the duration of mechanical ventilation connection in the intensive care unit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016073029123N1
Registration date:2016-10-11, 1395/07/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-11, 1395/07/20
Registrant information
Name
Musa Rafiee Vardanjany
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3224 4793
Email address
rafii.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Iran University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment Effect of retrograde autologous priming on clinical outcome of heart lung bypassing on patients undergoing coronary artery bypass grafting
Public title
Assessment effect of replacement liquid (crystalloid and colloid ) used for deairing circuits of cardiopulmonary bypass by patient own blood in patient undergoing coronary artery bypass grafting on clinical outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: adult patients undergoing coronary artery bypass surgery using cardiopulmonary bypass; no history of past heart surgery; age older than 18 and less than 70 years old; hemoglobin level greater than 8.5 and less than 14; body weight more than 45 kg and less than 100 kg; left ventricular ejection fraction greater than 25%.
Exclusion criteria: history of cardiac surgery; the patient or the patient's family withdraw from the study during the intervention period; emergency surgery; severe infection; clotting problems before surgery (INR> 1.2, aPTT> 40 s and blood platelet count less than 100 thousand per cubic meter); danapyroid and Lepyrudyn and dabigatran drug in the month before the operation; use Hemofilter and Cell Saver; the use of preoperative mechanical ventilation; dialysis before surgery; the existence of liver failure as (AST> 40 unit / L) and ((ALT> 40 unit / L before surgery.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Besides Milad Tower, Tehran, Hemmat Highway
City
Tehran
Postal code
1449614535
Approval date
2016-06-29, 1395/04/09
Ethics committee reference number
IR.IUMS.REC.1395.9311584002
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Changes in arterial blood gases
Timepoint
Before anesthesia, intraoperative and postoperative
Method of measurement
content of each gas in arterial blood Under the pressure of eac gas
2
Description
The need for blood and blood products transfusions during surgery
Timepoint
During Surgery
Method of measurement
The number of bags of blood and blood products in terms of unit
3
Description
The amount of postoperative blood and blood product transfusion
Timepoint
After surgery and during the hospitalization
Method of measurement
The number of bags of blood and blood products
4
Description
Duration of mechanical ventilation connection
Timepoint
During the intensive care unit
Method of measurement
Duration of mechanical ventilation connection based on hours
5
Description
Ejection fraction
Timepoint
After surgery in ward
Method of measurement
Ratio between strok volume to end diastolic volume according to percent
Secondary outcomes
1
Description
Hemoglobin - Hematocrit
Timepoint
During the operation, 12,24 and 48 hours after surgery
Method of measurement
The amount of hemoglobin according to milligrams per deciliter and hematocrit according percent
Intervention groups
1
Description
In the intervention group before the start of cardiopulmonary bypass and After the arterial cannulation by the surgeon we allow the patient blood reversely enter in arterial line by aorta pressure And at the same time we opened The bags Direction that had been placed on one of the output circuti and allowed equal the blood that inter from arterial line into circuit Priming fluid out.After leaving the arterial fluid circuit we have closed the arterial line and Action to spin pumps are connected to the oxygenator with slow motion And because the only output in the circuit is the collecting bags that connected to the circuit, liquid in the reservoir as much as possible inter in the collecting bag.In the final stage, when the patient's venous blood opens to the reservoir of the cardiopulmonary bypass, we attempt to extract this liquid from reservoir.Through the method that said in the intervention group In coordination with the Department of Anesthesiology to prevent hypotension,we extract 300-600 Milliliters of liquid prime and replace it with the patient's blood.
Category
Treatment - Other
2
Description
In the control group cardiopulmonary bypass circuits primed with conventional method (approximately1500 ml of crystalloid and colloid).And this fluid volume remains in the cardiopulmonary bypass circuit and inter to the patient body with the starting of the bypass.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart Hospital Shahid Rajaei
Full name of responsible person
Doctor Mohammad Zia Totonchy Ghorbany
Street address
Heart Hospital Shahid Rajaei, ValiAsr and Niayesh highway intersection
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Technology and Research Deputy of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Musa Rafiee Vardanjany
Position
Graduate student of blood circulation technology
Other areas of specialty/work
Street address
School of Nursing, Iran University of Medical Sciences, Rasheed Yaasemi street, Valiasr street
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Fax
+98 21 8888 2886
Email
musa rafiee7@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing, Iran University of Medical Sciences
Full name of responsible person
Dr. Nooredin Mohammadi
Position
Nursing Ph.D.
Other areas of specialty/work
Street address
School of Nursing, Rasheed Yaasami Street
City
Tehran
Postal code
Phone
+98 21 8828 8698
Fax
Email
nooredin.mohammadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Musa Rafiee Vardanjany
Position
Graduate student of blood circulation technology
Other areas of specialty/work
Street address
School of Nursing, Iran University of Medical Sciences, Rasheed Yaasemi street, Valiasr street
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Fax
+98 21 8888 2886
Email
musarafiee7@gmail.com
Web page address
http://www.fnm.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)