Determining the possibility of autologous blood transfusion in open radical prostatectomy surgery
Design
A single blind clinical trial including a parallel control group was performed on 30 patients based on referral priority.
Settings and conduct
Patients in need of radical open prostatectomy referred to Hasheminejad Hospital in Tehran will be included in the study if they have the conditions. After anesthesia and complete cardiovascular monitoring, 450 ml of blood is taken from the experimental group. Three times this amount of crystalloid is replaced. In the control group, no intervention is performed. Patients are evaluated at specified times.
Participants/Inclusion and exclusion criteria
Hemoglobin above 12; hematocrit above 30; age 35-80 years old; elective surgery; cardiac output above 45%; ASA class 1 & 2; patient satisfaction.
Inclusion criteria of study are no any complications during surgery.
Absence of any of the above condition will result to exclusion from the study.
Intervention groups
In this study, in the test group, autologous blood is injected before starting of surgery if required. In the control group, allogeneic blood will be used if needed.
Main outcome variables
Number of autologous blood transfusion; amount of AKI (BUN-Cr) in autologous and allogeneic blood transfusions; variation of hemoglobin, hematocrit, platelet count in autologous and allogeneic blood transfusion; surgeon satisfaction with homeostasis and surgery
General information
Reason for update
Acronym
ANH
IRCT registration information
IRCT registration number:IRCT20211206053289N1
Registration date:2021-12-24, 1400/10/03
Registration timing:prospective
Last update:2021-12-24, 1400/10/03
Update count:0
Registration date
2021-12-24, 1400/10/03
Registrant information
Name
Fatemeh Aghadjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2245 1623
Email address
f.aghadjani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the amount of blood transfusion required in candidated patients for radical open prostatectomy by acute normovolemic hemodilution
Public title
Comparison of the amount of blood transfusion required in candidate patients for prostatectomy surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hemoglobin will be over than 12
Hematocrit will be over than %30
Elective surgery is considered
Age of candidate shall be 35 till 80 years
Ejection fraction shall be over than %45
ASA class 1&2
Patient satisfaction
Exclusion criteria:
Liver disease
Heart failure
Kidney disease
Any hematological disease
Age
From 35 years old to 80 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are unaware of entering to the test or control groups but the rest of the study team are aware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Office of Anesthesiology and Intensive Care Group, Building No. 2, Rasoul Akram Hospital, Maziar Mansouri St., Sattar Khan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2020-11-17, 1399/08/27
Ethics committee reference number
IR.IUMS.FMD.REC.1399.562
Health conditions studied
1
Description of health condition studied
Autologous blood transfusion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of people who received only autologous blood
Timepoint
During surgery and up to 24 hours later
Method of measurement
Counting the number of blood bags consumed
Secondary outcomes
1
Description
The rate of drop in hemoglobin
Timepoint
24 hours after surgery
Method of measurement
Measurement of hemoglobin level by blood test
Intervention groups
1
Description
Intervention group: From this group of 15 people, 450 ml of blood was taken. It was replaced by 1.5 liters of crystalloid and then surgery was started. During and after the surgery, whenever it was estimated that the patient's bleeding needed to be compensated, autologous blood was injected, and if the bleeding was heavy, allogeneic blood was used.
Category
Treatment - Other
2
Description
Control group: After anesthesia and hemodynamic monitoring in this group of 15 people, surgery was started without any intervention and according to the patient's hemodynamics and the amount of bleeding during surgery, allogeneic blood was injected up to 24 hours later.
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Web page address
https://vcr.iums.ac.ir/
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
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
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Aghadjani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Office of Anesthesiology and Intensive Care Group, Building No. 2, Rasoul Akram Hospital, Maziar Mansouri St., Sattar Khan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
f.aghadjani@yahoo.com
Web page address
https://hrmc.iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Aghadjani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Office of Anesthesiology and Intensive Care Group, Building No. 2, Rasoul Akram Hospital, Maziar Mansouri St., Sattar Khan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 2245 1623
Email
F.ahgadjani@yahoo.com
Web page address
https://hrmc.iums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Aghadjani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Office of Anesthesiology and Intensive Care Group, Building No. 2, Rasoul Akram Hospital, Maziar Mansouri St., Sattar Khan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 2245 1623
Email
F.ahgadjani@yahoo.com
Web page address
https://hrmc.iums.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
Yes - There is a plan to make this available
Title and more details about the data/document
All test data of study can be shared after unidentified individuals.
When the data will become available and for how long
Access period will be 6 months after the result publish date
To whom data/document is available
Researchers working in academic, scientific and industrial institutes
Under which criteria data/document could be used
For using in scientific, medical works and for future researches which are working in academic, scientific and industrial institutions, citing the source
From where data/document is obtainable
Dr. Fatemeh Aghadjani
Email: f.ahghadjani@yahoo.com
Mobile number: 00989124090068
What processes are involved for a request to access data/document
Contact the person mentioned and submit a request with a valid address or e-mail to send data and documentation