comparison of the effect of retrograde autologous(rap) priming technique during extracorporeal circulation on blood transfusion rate in adult patients undergoing heart valve surgery
Evaluation of the effect of rap technique during extracorporeal circulation on blood transfusion rate in adult patients undergoing heart valve surgery
Design
This study was a randomized controlled clinical trial in the control and intervention groups is done.25 patients in each group(50 patients generally)in parallel
Settings and conduct
the study was performed on patients undergoing cardiac valve surgery.inclusion criteria include these items: cardiac valve replacement surgery;cardiac surgery with cardiopulmonary bypass;patienes with age over 18years.the patient enters the study randomly by choosing a blue or red card and in the control or intervention group.The study site is the operating and intensive care unit of afshar hospital in yazd province. blinding is not done in the study.with the knowledge of surgeon and anesthesiologist in the intervention group after priming the tubes with crystalloid fluid and before the start of extracorporeal circulation the clamp is removed from the arterial tube and then intravenously until the tubes are filled with the patients own blood and excess crystalloid fluid is removed from the circuit.in the control group the circuit is usually prime with crystalloid fluid and extracorporeal circulation begins.
Participants/Inclusion and exclusion criteria
Inclusion criteria:cardiac valve replacement surgery.age over 18 years.cardiopulmonary bypass . weight over 30kg.EF OVER 20%. Exclusion criteria:emergency surgery. thrombocytopenia. cardiac surgery that requires deep hypothermia. chronic kidney dieases
Intervention groups
group of patients performing the technique retrograd autologous priming and group of patients without technique retrograd autologous priming
Main outcome variables
blood transfusion rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200824048506N1
Registration date:2020-09-22, 1399/07/01
Registration timing:retrospective
Last update:2020-09-22, 1399/07/01
Update count:0
Registration date
2020-09-22, 1399/07/01
Registrant information
Name
Raziyeh Khodsiyani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3862
Email address
raz201364@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-10-21, 1398/07/29
Actual recruitment start date
2019-01-29, 1397/11/09
Actual recruitment end date
2019-10-21, 1398/07/29
Trial completion date
2019-10-24, 1398/08/02
Scientific title
comparison of the effect of retrograde autologous(rap) priming technique during extracorporeal circulation on blood transfusion rate in adult patients undergoing heart valve surgery
Public title
"assessing the effectiveness of retrograde autologous priming on blood transfusion"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
cardiac valve replacement surgery
cardiac surgery whit cardiopulmonary bypass
patienes whit age over 18 years
Exclusion criteria:
ejection fraction less than 20%
weight less than 30 kg
emergency surgery
thrombocytopenia
surgery requires deep hypothermia
chronic kidney disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
According to red and blue cards that choice by the patient herself
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 yazd shahid sadoughi university of medical sciences
Street address
boolvar shohadaie ghomnam
City
yazd
Province
Yazd
Postal code
8199966897
Approval date
2019-07-02, 1398/04/11
Ethics committee reference number
ir.ssu.medicine.rec.1398.098
Health conditions studied
1
Description of health condition studied
Cardiac surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
evaluation of RAP technique in blood intake
Timepoint
befor surgery.during surgery.time of hospitalization in ICU. discharge time
Method of measurement
getting blood sample and record the values in the questionnaire form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with heart valve problems who undergo RAP technique and surgery during cardiopulmonary bypass
Category
Treatment - Devices
2
Description
Control group: patients with heart valve problem who do not receive retrograde autologous priming undergo surgery and cardiopulmonary bypass
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
afshar general hospital
Full name of responsible person
Dr.Abdollahi
Street address
islamice repoblic boulevar
City
yazd
Province
Yazd
Postal code
8199966897
Phone
+98 35 3525 5011
Email
drhadadzadeh_mehdi@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr hadadzadeh
Street address
shohadaie gomnam boulevare
City
yazd
Province
Yazd
Postal code
8199966897
Phone
+98 35 3820 3862
Email
raz201364@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
10
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
Yazd University of Medical Sciences
Full name of responsible person
raziyeh khodsiani
Position
perfusionist
Latest degree
Bachelor
Other areas of specialty/work
cardiology
Street address
shohadaie gomnam boulevare
City
yazd
Province
Yazd
Postal code
8199966897
Phone
+98 35 3820 3862
Email
raz201364@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
raziyeh khodsiani
Position
perfusionist
Latest degree
Bachelor
Other areas of specialty/work
perfusionist
Street address
shohadaie gomnam boulevare
City
yazd
Province
Yazd
Postal code
8199966897
Phone
+98 35 3820 3862
Email
raz201364@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
raziyeh khodsiani
Position
perfusionist
Latest degree
Bachelor
Other areas of specialty/work
cardiology
Street address
shohadaie gomnam boulevare
City
yazd
Province
Yazd
Postal code
8199966897
Phone
+98 35 3820 3862
Email
raz201364@gmail.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