The effect of defroxamine on neurological and radiological outcome after spontaneous intracerebral hemorrhage
Design
This study will be performed as a randomized clinical trial (4 blocks), one-sided blind, with control group, with parallel groups and as a phase 2-3 with the participation of 42 patients with spontaneous cerebral hemorrhage.
Settings and conduct
This study will be performed with the participation of 42 patients with spontaneous cerebral hemorrhage admitted to Shohada Hospital (Tabriz University of Medical Sciences). Patients will be given two drugs, deferoxamine (intervention group - for three consecutive days) and placebo (control group, for three consecutive days) during hospitalization. The data analyzer will be unaware of the grouping of patients and will be blind during the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria include stroke, spontaneous cerebral hemorrhage, and consent to participate in the study, and exclusion criteria include brain surgery, stroke over the past six months, and deferoxamine sensitivity.
Intervention groups
In this study, a randomized, single-blind clinical trial will be performed in Shohada Hospital (Tabriz University of Medical Sciences). Turn) and control (placebo administration for three consecutive days and once a day) will be divided and after the intervention, their level of consciousness will be compared.
Main outcome variables
Level of consciousness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N30
Registration date:2022-05-13, 1401/02/23
Registration timing:prospective
Last update:2022-05-13, 1401/02/23
Update count:0
Registration date
2022-05-13, 1401/02/23
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-31, 1401/03/10
Expected recruitment end date
2022-10-02, 1401/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of defroxamine on neurological and radiological outcome after spontaneous intracerebral hemorrhage
Public title
Deferoxamine on neurological and radiological implications for cerebral hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Brain stroke
Spontaneous cerebral hemorrhage
Satisfaction to participate in the study
Exclusion criteria:
Requires brain surgery
Stroke over the last six months
Hypersensitivity to deferoxamine
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
IR.TBZMED.REC.1401.142
Health conditions studied
1
Description of health condition studied
level of consciousness
ICD-10 code
R40.244
ICD-10 code description
Other coma, without documented Glasgow coma scale score, or with partial score reported
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Mohammad Shimia
Street address
Shohada Hospital, Golshahr Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 41 3335 5921
Email
Shimia@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Shahid Madani Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
P_shahabi@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Shimia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Shimia@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Yaser Mousavi
Position
Neurosurgery assistant
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3334 7054
Fax
Email
Yaser_musavi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available