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IRCT20190325043107N30 IRCT 2022-05-13 Tabriz University of Medical Sciences Deferoxamine on neurological and radiological implications for cerebral hemorrhage The effect of defroxamine on neurological and radiological outcome after spontaneous intracerebral hemorrhage 2022-05-31 anticipated 42 Complete https://irct.ir/trial/63470 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block random division method (4 blocks) is used. One of the study partners, for whom no blinding was performed, named the method of treatment of defroxamine with the letter A and the method of treatment of placebo with the letter B. The researcher then distributes packages A and B among the patients referred to participate in the study by block random division method (4). Then, from the created blocks, enough blocks are randomly selected to reach the required sample size. To make a random sequence, we give possible blocks (11 blocks) from one to 11 numbers. Depending on the sample size, any number of 4 blocks that are needed will be used. Select the number of blocks from the table of random numbers and based on these numbers, the sequence of blocks in each group will be determined.Finally, random allocation will be done with the help of 11 quadruple blocks, Blinding description: The statistical consultant of this project will be unaware of the type of grouping of participants; The final results will be delivered to the statistical consultant. As the statistical consultant will not be in the process of grouping the participants; Therefore, he is blind during the study. 2-3 level of consciousness. Intervention 1: Intervention group: Twenty-one patients with a diagnosis of spontaneous bleeding after random allocation will be included in this study. After being admitted to the relevant ward, deferoxamine (manufactured by Obaidi Company) will be injected for three consecutive days (once a day). Consciousness status will be measured before the intervention, one week and one month after the intervention using the GCS instrument. Intervention 2: Control group: Twenty-one patients with a diagnosis of spontaneous bleeding after random allocation will be included in this study. After being admitted to the relevant ward, placebo (manufactured by Obaidi Company) will be injected for three consecutive days (once a day). Consciousness status will be measured before the intervention, one week and one month after the intervention using the GCS instrument. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Not more information
public Mohammad Shimia
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5165665631 +98 41 3335 7310 Shimia@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Seyed Yaser Mousavi
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5165665631 +98 41 3334 7054 Yaser_musavi@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Brain stroke Spontaneous cerebral hemorrhage Satisfaction to participate in the study 18 years 75 years Both Requires brain surgery Stroke over the last six months Hypersensitivity to deferoxamine R40.244 Other coma, without documented Glasgow coma scale score, or with partial score reported Treatment - Drugs Placebo Intervention group: Twenty-one patients with a diagnosis of spontaneous bleeding after random allocation will be included in this study. After being admitted to the relevant ward, deferoxamine (manufactured by Obaidi Company) will be injected for three consecutive days (once a day). Consciousness status will be measured before the intervention, one week and one month after the intervention using the GCS instrument. Control group: Twenty-one patients with a diagnosis of spontaneous bleeding after random allocation will be included in this study. After being admitted to the relevant ward, placebo (manufactured by Obaidi Company) will be injected for three consecutive days (once a day). Consciousness status will be measured before the intervention, one week and one month after the intervention using the GCS instrument. Level of consciousness. Timepoint: Before the intervention, one week and one month after the end of the intervention. Method of measurement: With the help of GCS criteria. Tabriz University of Medical Sciences Approved 2022-05-11 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)