Objective: The main purpose of this study is evaluating the effect of deferoxamine on hemorrhagic transformation in patients with acute ischemic stroke in middle cerebral artery territory. Design: Randomized controlled clinical trial, single blinded, trial phase 2. Setting and conduct: 64 patients with acute ischemic stroke in middle cerebral artery territory will select and randomly will divide into two treatment and control groups. Control group will receive routine treatment of stroke but treatment group will receive routine treatment plus IV infusion of deferoxamine(40 mg/kg/day for 3 days). Serum ferritin level in all patients will be measured in first (baseline) and fourth day and CT scan will be done on patient in fourth and seventh day. Inclusion criteria: Acute ischemic stroke in middle cerebral artery territory. Exclusion criteria: renal failure; hemorrhagic infarction; infarction in other arterial territory; coagulopathies and history of anticoagulant drugs; anemia. Intervention: Deferoxamine infusion. Main outcome: Reduction of hemorrhagic transformation.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2013111915444N2
Registration date:2014-11-12, 1393/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-12, 1393/08/21
Registrant information
Name
Ahmad Maghuli
Name of organization / entity
Ahvaz Jondishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 1984
Email address
a.maghuli@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-02-18, 1393/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of deferoxamine on hemorrhagic transformation of middle cerebral artery stroke
Public title
Effect of deferoxamin on stroke
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Acute ischemic stroke in middle cerebral artery territory. Exclusion criteria: renal failure; hemorrhagic stroke; stroke in other arterial territory; coagulopathies and history of anticoagulant drugs; anemia
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
"Ethics committee of Ahvaz Jondishapur University of Medical Sciences"
Street address
Jondishapur University of Medical Sciences, Golestan blvd
City
Ahvaz
Postal code
6135715794
Approval date
2013-11-02, 1392/08/11
Ethics committee reference number
ajums.REC.1392.164
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
I63.5
ICD-10 code description
Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
2
Description of health condition studied
intracerebral haemorrhage
ICD-10 code
I69.1
ICD-10 code description
Sequelae of intracerebral haemorrhage
Primary outcomes
1
Description
Serrum ferritin
Timepoint
First and fourth day of addmission
Method of measurement
Microgram per litre with ferritin test kit
Secondary outcomes
1
Description
Hemorrhagic transformation
Timepoint
Fourth and seventh day
Method of measurement
CT scan
Intervention groups
1
Description
Intervention group: Deferoxamin, vial 500 mg, dose of 40 mg/kg/day, venous transfusion for 3 days
Category
Treatment - Drugs
2
Description
control group: without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan hospital
Full name of responsible person
Ahmad Maghuli
Street address
Neurology ward, Golestan hospital, Golestan blvd
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Dr Nader Saki
Street address
Central research center, Jondishapur University of Medical Sciences, Golestan blvd
City
Ahvaz
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jondishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Ahmad Maghuli
Position
Medical Intern
Other areas of specialty/work
Street address
Neurology ward, Golestan hospital, Golestan blvd
City
Ahvaz
Postal code
6135733118
Phone
+98 61 1336 1984
Fax
-
Email
ahmad.m1368@yahoo.com; a.maghuli@ajums.ac.ir
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondishapoor University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mohamadiani Nezhad
Position
Neurologist
Other areas of specialty/work
Street address
Neurology ward, Golestan hospital, Golestan blvd
City
Ahvaz
Postal code
613573318
Phone
+98 61 1374 3012
Fax
-
Email
ehsan_neuro@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Ahmad Maghuli
Position
Medical Intern
Other areas of specialty/work
Street address
Neurology ward, Golestan hospital, Golestan blvd
City
Ahvaz
Postal code
6135733118
Phone
+98 61 1374 3012
Fax
-
Email
ahmad.m1368@yahoo; a.maghuli@ajums.ac.ir
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)