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IRCT20201003048904N1 IRCT 2020-10-11 Boushehr University of Medical Sciences Effect of Blood Transfusion in Covid-19 Evaluation of the Effect of Blood Transfusion on the Atrial Blood Oxygen Saturation percentage in COVID-19 patients 2020-10-11 anticipated 40 Complete https://irct.ir/trial/51364 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by the Blocked Randomization method. So that two groups T and C are considered as intervention and control groups. Allocating two groups equally in each block can be: TTCC, TCTC, TCCT, CCTT, CTCT, CTTC. Considering that there are 40 patients in each group, a total of 80 samples are needed, so from the above blocks, 20 blocks are randomly selected (placing all 6 types of blocks in a container and selecting it randomly and by placement). And they are written in a chain, for example: TTCC-CCTT-TTCC-CTTC-CTCT-TCTC-TCCT-TCCT-CTTC-TTCC… Group T patients will eventually be in the intervention group and group C patients will be in the control group, and it will be pre-determined in which group the patient will be placed, Blinding description: In this study, the data analyzer is not aware of which group is the control group and which group is in the intervention group. N/A Respiratory status of patients with Covid 19. Intervention 1: Intervention group: In this group, patients diagnosed with COVID19 who meet the inclusion criteria, in addition to receiving standard treatments according to the national protocol, receive a unit of blood (packed cell). Intervention 2: Control group: In this group, Covid 19 patients who meet the inclusion criteria receive standard treatments based on the national protocol and other therapeutic interventions during hospitalization, such as packed cell blood products or other interventions outside. Do not receive standard treatment. Yes - There is a plan to make this available What will be shared: The main variables and outcomes studied will be published: Percentage of blood oxygen saturation, clinical symptoms, laboratory findings, and demographic variables. When: 4 months after publishing the results To whom: Researchers member of formal research institutes and faculty members Conditions: To integrate data with other studies Where to obtain: Dr Farhad Abbasi: f_abbasi55@yahoo.com How to obtain: The objectives and scope of the draft research plan are reviewed and approved if they are consistent with the data. Comments:
public Farhad Abbasi
No.15, Erfan 16 alley, Motahari St.
Bushehr Iran (Islamic Republic of) 7516654933 +98 77 3358 0309 f_abbasi55@yahoo.com Boushehr University of Medical Sciences scientific Farhad abbasi
No.15, Erfan 16 alley, Motahari St., Bushehr, Iran
Bushehr Iran (Islamic Republic of) 7516654933 +98 77 3358 0309 f_abbasi55@yahoo.com Boushehr University of Medical Sciences Iran (Islamic Republic of) Confirmation of Covid 19 The patient's clinical condition confirms the indication for hospitalization. Chest CT scan shows more than 25% of pulmonary involvement. SPO2 equal to or less than 94% on the day of admission Hemoglobin should be less than 12 g / dl (women) and less than 13 g / dl (men) on the day of admission. Absence of absolute or partial contraindications including history of allergies, anaphylaxis, history of thrombosis, pregnancy Satisfaction of the patient or his/her legal companions to participate in the study 18 years no limit Both Contraindications for receiving blood. The patient's unwillingness to receive blood. The need to receive blood as a treatment in the course of the disease for other reasons. U07.1 COVID-19, virus identified Treatment - Other Treatment - Other Intervention group: In this group, patients diagnosed with COVID19 who meet the inclusion criteria, in addition to receiving standard treatments according to the national protocol, receive a unit of blood (packed cell). Control group: In this group, Covid 19 patients who meet the inclusion criteria receive standard treatments based on the national protocol and other therapeutic interventions during hospitalization, such as packed cell blood products or other interventions outside. Do not receive standard treatment. Blood oxygen saturation. Timepoint: Admission day, The first day after the blood transfusion, The third day after the blood transfusion. Method of measurement: Pulse oximetry. Dyspnea status. Timepoint: Admission day, The first day after the blood transfusion, The third day after the blood transfusion. Method of measurement: Subjective: question from the patient. Objective: respiratory rate count in a minute. Boushehr University of Medical Sciences Approved 2020-09-16 Ethics Committee of Bushehr University of Medical Sciences Rishahr St. Bushehr University of Medical Sciences Campus Bushehr Boushehr Iran (Islamic Republic of)