Protocol summary

Study aim
Effect of Milrinonein treatment on vasospasm in patients with ‎subarachnoid hemorrhage
Design
This is a Clinical and double-blind clinical trial. 32 candidates for subarachnoid hemorrhage referred to Valiasr Hospital are entered.We will divide patients in two groups randomly.
Settings and conduct
This is a Clinical and double-blind clinical trial. 32 candidates for aneurysms referred to Valiasr Hospital are entered.The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).An analyzer used to treat a patient don't aware.
Participants/Inclusion and exclusion criteria
inclusion criteria: both of gender, Patients with subarachnoid hemorrhage and vasospasm Exclusion criteria: Dissatisfaction
Intervention groups
During digital subtraction angiography, we inject 50 micrograms per kilogram melirinone is initially and in following 0.5 to 0.75 micrograms per kilogram per minute melirinone for patients .We compare patients before and after angiography.During digital subtraction angiography, we inject routine drug for patients . It is repeat 10 minutes after angiography injection. We perform by a neurologist TransCranial Doppler sonography in control group.
Main outcome variables
Determine vasoaspasm of the cerebrovascular

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N82
Registration date: 2018-07-11, 1397/04/20
Registration timing: registered_while_recruiting

Last update: 2018-07-11, 1397/04/20
Update count: 0
Registration date
2018-07-11, 1397/04/20
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-29, 1396/08/07
Expected recruitment end date
2019-10-29, 1398/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Milrinonein treatment vasospasm in patients with ‎subarachnoid hemorrhage
Public title
Effect of Milrinonein treatment vasospasm in patients with ‎subarachnoid hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
both of gender Patients with subarachnoid hemorrhage and vasospasm
Exclusion criteria:
Dissatisfaction
Age
From 30 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind. Outcome evaluator and analyzer and participant are blind (double-blind). Outcome evaluator and analyzer don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Approval date
2017-05-01, 1396/02/11
Ethics committee reference number
IR.ARAK.MU.REC.1396.2

Health conditions studied

1

Description of health condition studied
subarachnoid hemorrhage
ICD-10 code
I60
ICD-10 code description
Nontraumatic subarachnoid hemorrhage

Primary outcomes

1

Description
vasospasm
Timepoint
Before and after intervention
Method of measurement
TransCranial Doppler sonography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: During digital subtraction angiography, we inject 50 micrograms per kilogram melirinone is initially and in following 0.5 to 0.75 micrograms per kilogram per minute melirinone for patients . It is repeat 10 minutes after angiography injection. We perform by a neurologist TransCranial Doppler sonography.
Category
Treatment - Drugs

2

Description
Control group: During digital subtraction angiography, we inject routine drug for patients . It is repeat 10 minutes after angiography injection. We perform by a neurologist TransCranial Doppler sonography.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Mohsen Dalvandi
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3417 3645
Fax
+98 86 3222 2003
Email
dalvandi@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr ajmandzadegan
Street address
Vice chancellor for research, Payambar azam complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
38149578558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza kamali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86132222003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohsen Dalvandi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
dalvandi@arakmua.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Reza Mansoubi
Position
resident of neurosurgery
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
bardiamansoubi1390@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
When we publish article in journal.
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Mohsen Dalvandi
What processes are involved for a request to access data/document
They have to write letters to the professors and the university
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