Evaluation the effect of autologous versus allogeneic blood transfusion on clinical and paraclinical outcomes in patients undergoing selective thorax and abdominal surgery: a randomized clinical trial
To assess the effect of autologous versus allogeneic blood transfusion on clinical and paraclinical outcomes in patients undergoing selective thorax and abdominal surgery
Design
This is a phase III randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using drawing of lots.
Settings and conduct
This study will be conducted at the Besat Hospital in Hamadan city, involving 100 eligible patients undergoing selective thorax and abdominal surgery. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. However, it should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 80 years;
Indications for non-emergency chest and abdominal surgery;
Hemoglobin above 11, hematocrit above 30, and platelets above 150,000 before surgery;
Exclusion criteria:
Heart or lung disease or high blood pressure;
Seizure registration;
AIDS or hepatitis
Intervention groups
Intervention group:
Autologous blood injection of 3 to 4 units according to the patient's needs during surgery
Control group:
Allogeneic blood injection of 3 to 4 units according to the patient's needs during surgery
Main outcome variables
Hemoglobin and hematocrit levels, average days of hospitalization, occurrence of hypersensitivity reactions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N507
Registration date:2024-04-17, 1403/01/29
Registration timing:prospective
Last update:2024-04-17, 1403/01/29
Update count:0
Registration date
2024-04-17, 1403/01/29
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of autologous versus allogeneic blood transfusion on clinical and paraclinical outcomes in patients undergoing selective thorax and abdominal surgery: a randomized clinical trial
Public title
Effect of autologous versus allogeneic blood transfusion on clinical and paraclinical outcomes in patients undergoing selective surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 80 years
Indications for non-emergency chest and abdominal surgery
Hemoglobin above 11, hematocrit above 30, and platelets above 150,000 before surgery
Exclusion criteria:
Heart or lung disease or high blood pressure
Seizure registration
AIDS
Hepatitis
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly taken and the patient is assigned to the intervention or control group.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-11-25, 1402/09/04
Ethics committee reference number
IR.UMSHA.REC.1402. 561
Health conditions studied
1
Description of health condition studied
Blood transfusion on clinical and paraclinical outcomes
ICD-10 code
T80
ICD-10 code description
Complications following infusion, transfusion and therapeutic injection
Primary outcomes
1
Description
Hemoglobin and hematocrit levels
Timepoint
48 hours after blood transfusion
Method of measurement
By taking blood samples
2
Description
Average days of hospitalization
Timepoint
After surgery
Method of measurement
According to the medical record
Secondary outcomes
1
Description
Occurrence of hypersensitivity reactions
Timepoint
Immediately after blood transfusion and 24 hours later
Method of measurement
With clinical examination and investigation of blood inflammatory factors
Intervention groups
1
Description
Intervention group: Autologous blood injection (taken from the person before surgery and stored in the blood bank and used during surgery) of 3 to 4 units according to the patient's needs during surgery
Category
Treatment - Other
2
Description
Control group: Allogeneic blood injection (blood donated by volunteers that is available in the blood bank and is used during surgery if the patient needs it), 3 to 4 units according to the patient's needs during surgery
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Hamed Nayeri
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
hamed_nayeri1102@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Hamed Nayeri
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
hamed_nayeri1102@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rea Yoosefi Ahamad Abadi
Position
Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
rreza.yousefi87@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available