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Investigating the effect of subcutaneous erythropoietin on blood transfusions requirement in trauma patients admitted to the surgical intensive care unit (SICU): A Randomized Clinical Trial

Protocol summary

Study aim
Determining the effect of erythropoietin on the need for blood transfusion in trauma patients admitted to the surgical intensive care unit of Shahid Jalil Hospital, Yasuj.
Design
Controlled clinical trial, with parallel groups, single-blind, randomized, phase 3 on 140 patients. Block method for randomization
Settings and conduct
Trauma patients without the need for emergency laparotomy and with femoral fracture with or without other trauma, who have hemoglobin of 8 to 12 g/dL on the day of admission to the surgical ICU of Shahid Jalil Hospital, Yasuj, are eligible for entry into the study. Blocking method will be used to allocate individuals to the study groups Outcomes will be assessed by an independent assessor who is unaware of the subject's allocation (single-blind design). In this study, a dose of 30,000 units of recombinant human erythropoietin (rHuEPO) will be administered subcutaneously every three days (on days 3, 6, 9, and 12) for intervention group. Both intervention and control groups will receive the standard care protocol for trauma patients in the SICU.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages 18-65 years with trauma injuries with femur fracture admitted to SICU with hemoglobin level of 8 to 12 g/dL upon admission to ICU Exclusion criteria: pre-existing hematological disorders (such as polycythemia vera), history of erythropoietin sensitivity, current pregnancy or breastfeeding, chronic kidney disease requiring dialysis, history of erythropoietin or other red blood cell stimulating agents, history of hypertension, cancer patients, history of thrombosis or current acute thrombosis.
Intervention groups
Intervention group receiving erythropoietin and standard care and control group receiving standard care without erythropoietin
Main outcome variables
Number of blood transfusions required during SICU stay

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250621066213N1
Registration date: 2025-07-01, 1404/04/10
Registration timing: prospective

Last update: 2025-07-01, 1404/04/10
Update count: 0
Registration date
2025-07-01, 1404/04/10
Registrant information
Name
Saeid Sharifi Golshan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 341 7018
Email address
saeidsharifigolshan5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-11, 1404/04/20
Expected recruitment end date
2025-11-11, 1404/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of subcutaneous erythropoietin on blood transfusions requirement in trauma patients admitted to the surgical intensive care unit (SICU): A Randomized Clinical Trial
Public title
Investigating the effect of subcutaneous erythropoietin on blood transfusions requirement in trauma patients admitted to the surgical intensive care unit (SICU)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients 18-65 years old Patients admitted to the SICU with traumatic injuries associated with femur fractures Hemoglobin level 8 to 12 g/dL upon admission to the ICU Informed consent has been obtained from the patient or their legal representative.
Exclusion criteria:
Patients with pre-existing hematological disorders (such as polycythemia Vera) Patients with a history of erythropoietin sensitivity Pregnant or breastfeeding women Patients with chronic kidney disease who require dialysis Patients who have previously received erythropoietin or other red blood cell stimulating agents Patients with a history of high blood pressure Cancer patients Patients with a history of thrombosis or current acute thrombosis
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
The block method will be used. The groups are defined as codes A and B. Before assigning individuals to one of the groups, a list of these letters (blocks A, B) is formed. Each of the referring and eligible individuals is assigned to one of the groups. To avoid the risk of predicting the allocation of individuals to different groups, blocks of different sizes (2, 4, 6, and 8) will be created and, accordingly, they will be placed in two intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to reduce bias, the intervention will be implemented by trained therapists, and the outcome assessment will be conducted by an independent evaluator unaware of the subjects' grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences، Shahid Motahari Blvd، Yasuj، Postal code 7591741417
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2025-05-25, 1404/03/04
Ethics committee reference number
IR.YUMS.REC.1404.038

Health conditions studied

1

Description of health condition studied
Investigating the need for blood transfusion in trauma patients receiving subcutaneous erythropoietin.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Number of blood transfusions required during SICU stay
Timepoint
During hospitalization in the intensive care unit
Method of measurement
Number of units of blood transfused

Secondary outcomes

1

Description
Hemoglobin level
Timepoint
When admitted to the ICU, weekly intervals, and discharged from the ICU...
Method of measurement
grams per deciliter

2

Description
Hematocrit level
Timepoint
When admitted to the ICU, weekly intervals, and discharged from the ICU...
Method of measurement
percentage

3

Description
Length of stay in the intensive care unit
Timepoint
When discharged from the ICU
Method of measurement
number of days

4

Description
Occurrence of thromboembolic complications
Timepoint
during ICU stay
Method of measurement
yes/no

Intervention groups

1

Description
Intervention group: Intervention group receiving erythropoietin and standard care .A dose of 30,000 units of recombinant human erythropoietin (rHuEPO) will be administered subcutaneously once every three days (on days 3, 6, 9, and 12)
Category
Treatment - Drugs

2

Description
Control group: control group receiving standard care without erythropoietin
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dowlatabad Martyrs' Educational and Medical Center and Shahid Dr. Ghorbanali Jalil Hospital
Full name of responsible person
Masoumeh Alizadeh
Street address
Dowlatabad Martyrs' Educational and Medical Center and Shahid Dr. Ghorbanali Jalil Hospital، Qarni Boulevard, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7001
Fax
+98 74 3333 7001
Email
jalilhospital@yums.ac.ir
Web page address
https://shahidjalil.yums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sirus Salehnasab
Street address
Deputy of Research and Technology, Yasuj University of medical Sciences, Shahid Motahari Blvd, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6070
Fax
+98 74 3334 6071
Email
sci@yums.ac.ir
Web page address
https://sci.yums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No.5, Unit 2, Tohid 6Alley, Baqerkhan Street, Rahnamayi square, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591985148
Phone
+98 74 3232 4568
Email
Alizadeh.md6010@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No.5, Unit 2, Tohid 6Alley, Baqerkhan Street, Rahnamayi square, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591985148
Phone
009832324568
Email
Alizadeh.md6010@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No.5, Unit 2, Tohid 6Alley, Baqerkhan Street, Rahnamayi square, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591985148
Phone
009832324568
Email
Alizadeh.md6010@gmail.com

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
In pdf format and via email after verification of the real requesting party
When the data will become available and for how long
No restrictions
To whom data/document is available
Real scientific characters
Under which criteria data/document could be used
To assist in the scientific study of statistics in order to advance science
From where data/document is obtainable
To personal email alizadeh.md6010@gmail.com
What processes are involved for a request to access data/document
After receiving the request via email with complete details of the workplace, address, and telephone number, after checking the verification of the real person and the accredited scientific center, a response will be sent within one month.
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