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IRCT20190121042444N4 IRCT 2021-10-20 Shahid Beheshti University of Medical Sciences The effect of injectable iron on blood transfusion rate in patients with hip fractures Evaluation of allogeneic transfusion after injection of injectable iron in patients’ candidates for intertrochanteric fracture surgery 2021-09-22 anticipated 78 Complete https://irct.ir/trial/58005 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study are divided into two categories of control and intervention using Android randomization software IZE, so that first each patient raises a number and it is entered in the software and the output of the software shows a A and B groups. 78 patients will participate in this study and 39 of them will be allocated to intervention and the other 39 will enter control group based on randomization application, Blinding description: Patients are introduced to the data collector to continue the study so that only the numbers A and B are written on the form in the patient's hand, and as a result, the patient and the data collector are not aware of the patient group. 3 Femoral fractures. Intervention 1: Intervention group: The group will be monitored by a specific orthopedic professor under the treatment protocol of intertrochantric fracture treatment center of Shohada Tajrish Hospital Trauma Center. And hemoglobin less than 8 or less than 9 grams per deciliter (in patients with a history of cardiorespiratory disease). Patients received a slow infusion of Venofer made by the French company Wifor at a dose of 600 mg (each ampoule of Venofer in 250 cc of diluted 9% saline solution will be infused once a day for 90 minutes from 10 days before surgery). Intervention 2: Control group: No intervention will be performed in this group. Standard treatment will be administrated. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main consequence or the like, can be shared. When: Start of access period from 1401 To whom: Only for researchers in academic and scientific institutions Conditions: Only data analysis is possible Where to obtain: Dr. Faranak Behnaz, Address: Tehran, Tajrish Square, Shohada Experience Hospital, Tel: 0098212271174 How to obtain: After submitting the application, a maximum of one week will be answered Comments:
public Faranak Behnaz
Shohada Hospital, Tajrish SQ, Tehran , Iran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2274 1174 faranak.behnaz@gmail.com Shahid Beheshti University of Medical Sciences scientific Rahmatollah Mohammadzadeh
Shohada Hospital,Tajrish SQ
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2274 1174 dr.rh.mohammadzadeh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Intertrochanteric fractures Age over 65 years 65 years 90 years Both Excessive iron disorders Other anemic disorders due to diseases such as thalassemia Chronic Diseases Megaloblastic anemia Sensitivity to oral or injectable iron Treatment of asthma with clopidogrel or with salicylic acetyl Blood coagulation disorders Liver diseases Hypothyroidism or hyperthyroidism Chronic renal failure S72.1 Intertrochanteric fracture Treatment - Drugs Diagnosis Intervention group: The group will be monitored by a specific orthopedic professor under the treatment protocol of intertrochantric fracture treatment center of Shohada Tajrish Hospital Trauma Center. And hemoglobin less than 8 or less than 9 grams per deciliter (in patients with a history of cardiorespiratory disease). Patients received a slow infusion of Venofer made by the French company Wifor at a dose of 600 mg (each ampoule of Venofer in 250 cc of diluted 9% saline solution will be infused once a day for 90 minutes from 10 days before surgery). Control group: No intervention will be performed in this group. Standard treatment will be administrated. Bleeding volume. Timepoint: Before the intervention and during surgery. Method of measurement: Based on measurements of the surgical field and the volume of suction. Number of PRBC received. Timepoint: Before the intervention and during surgery. Method of measurement: Number of blood bags injected. Hemoglobin. Timepoint: Before intervention and 1 hour after surgery and 7 days after surgery. Method of measurement: Measurement of serum levels in a blood test. Hematocrit. Timepoint: Before intervention and 1 hour after surgery and 7 days after surgery. Method of measurement: Measurement of serum levels in a blood test. Ferritin. Timepoint: Before intervention and 1 hour after surgery and 7 days after surgery. Method of measurement: Measurement of serum levels in a blood test. Reticulocytes. Timepoint: Before intervention and 1 hour after surgery and 7 days after surgery. Method of measurement: Measurement of serum levels in a blood test. Red blood cell count. Timepoint: Before intervention and 1 hour after surgery and 7 days after surgery. Method of measurement: Measure the number in the blood test. Iron level. Timepoint: Before intervention and 1 hour after surgery and 7 days after surgery. Method of measurement: Measurement of serum levels in a blood test. Shahid Beheshti University of Medical Sciences Approved 2021-08-09 Ethics committee of Shahid Behesti University of Medical Sciences Yaman Ave,Velenjak Tehran Tehran Iran (Islamic Republic of)