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IRCT20250621066213N1 IRCT 2025-07-01 Yasouj University of Medical Sciences Investigating the effect of subcutaneous erythropoietin on blood transfusions requirement in trauma patients admitted to the surgical intensive care unit (SICU) 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 2025-07-11 anticipated 140 Complete https://irct.ir/trial/84474 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Investigating the need for blood transfusion in trauma patients receiving subcutaneous erythropoietin.. Intervention 1: 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). Intervention 2: Control group: control group receiving standard care without erythropoietin. Yes - There is a plan to make this available What will be shared: In pdf format and via email after verification of the real requesting party When: No restrictions To whom: Real scientific characters Conditions: To assist in the scientific study of statistics in order to advance science Where to obtain: To personal email alizadeh.md6010@gmail.com How to obtain: 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. Comments:
public Zeinab Alizadeh
No.5, Unit 2, Tohid 6Alley, Baqerkhan Street, Rahnamayi square, Yasuj
Yasuj Iran (Islamic Republic of) 7591985148 +98 74 3232 4568 Alizadeh.md6010@gmail.com Yasouj University of Medical Sciences scientific Zeinab Alizadeh
No.5, Unit 2, Tohid 6Alley, Baqerkhan Street, Rahnamayi square, Yasuj
Yasuj Iran (Islamic Republic of) 7591985148 009832324568 Alizadeh.md6010@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 65 years Both 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 Treatment - Drugs N/A 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) Control group: control group receiving standard care without erythropoietin 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. Hemoglobin level. Timepoint: When admitted to the ICU, weekly intervals, and discharged from the ICU. Method of measurement: grams per deciliter. Hematocrit level. Timepoint: When admitted to the ICU, weekly intervals, and discharged from the ICU. Method of measurement: percentage. Length of stay in the intensive care unit. Timepoint: When discharged from the ICU. Method of measurement: number of days. Occurrence of thromboembolic complications. Timepoint: during ICU stay. Method of measurement: yes/no. Yasouj University of Medical Sciences Approved 2025-05-25 Ethics Committee of Yasuj University of Medical Sciences Yasuj University of Medical Sciences، Shahid Motahari Blvd، Yasuj، Postal code 7591741417 Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)