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IRCT20211206053289N1 IRCT 2021-12-24 Iran University of Medical Sciences Comparison of the amount of blood transfusion required in candidate patients for prostatectomy surgery ANH Comparison of the amount of blood transfusion required in candidated patients for radical open prostatectomy by acute normovolemic hemodilution 2022-01-21 anticipated 30 Complete https://irct.ir/trial/60625 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: The participants are unaware of entering to the test or control groups but the rest of the study team are aware. N/A Autologous blood transfusion. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All test data of study can be shared after unidentified individuals. When: Access period will be 6 months after the result publish date To whom: Researchers working in academic, scientific and industrial institutes Conditions: For using in scientific, medical works and for future researches which are working in academic, scientific and industrial institutions, citing the source Where to obtain: Dr. Fatemeh Aghadjani Email: f.ahghadjani@yahoo.com Mobile number: 00989124090068 How to obtain: Contact the person mentioned and submit a request with a valid address or e-mail to send data and documentation Comments:
public Fatemeh Aghadjani
Office of Anesthesiology and Intensive Care Group, Building No. 2, Rasoul Akram Hospital, Maziar Mansouri St., Sattar Khan St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 1000 f.aghadjani@yahoo.com Iran University of Medical Sciences scientific Fatemeh Aghadjani
Office of Anesthesiology and Intensive Care Group, Building No. 2, Rasoul Akram Hospital, Maziar Mansouri St., Sattar Khan St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 2245 1623 F.ahgadjani@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) 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 35 years 80 years Male Liver disease Heart failure Kidney disease Any hematological disease Treatment - Other Treatment - Other 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. 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. 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. The rate of drop in hemoglobin. Timepoint: 24 hours after surgery. Method of measurement: Measurement of hemoglobin level by blood test. Iran University of Medical Sciences Approved 2020-11-17 Ethics committee of Iran University of Medical Sciences Office of Anesthesiology and Intensive Care Group, Building No. 2, Rasoul Akram Hospital, Maziar Mansouri St., Sattar Khan St. Tehran Tehran Iran (Islamic Republic of)