The effect of hypothermia on the final outcome of patients with acute stroke
Design
One-Blind randomized clinical trial with control group. Sampling was done by cluster random sampling and then divided into control and experimental groups by random method.
Settings and conduct
The population of the study included all patients with acute stroke in Hamadan province. After selecting the samples and dividing them into control and
experimental groups, the intervention will be performed for 3 hours on the patients in the experimental group and the results of the two groups will be compared. Blinding is done by preventing the samples from being informed of their group type.
Participants/Inclusion and exclusion criteria
1. Having a hemorrhagic or ischemic stroke
2. Age over 18 years old
3. Informed consent form signed by the patient or his/her representative
4. Not having severe heart failure - Grade 2 and 3 based on cardiologist diagnosis
5. Absence of pulmonary embolism or acute myocardial infarction
6. Absence of any cardiac arrhythmia or ventricular or atrioventricular block in the ECG
7. Absence of acute or chronic sinusitis or current skull bone fracture
8. Not getting septicemia or bacteremia or severe blood infection at the admission time
9. Not having fever above 38.5 ° C when admitted
10. Absence of known blood diseases with increase the risk of thrombosis such as cryoglobulinemian, cold agglutination, or sickle cell anemia
11. Absence of known spastic venous complications, such as Raynaud's disease, or thromboangiitis obliterans
12. Weight less than 120 kg
Intervention groups
Hypothermia is performed by the cooling device on the patients in the intervention group, but for the control group only routine treatment is performed.
Main outcome variables
FOUR Score; APACHE score; NIHSS score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181105041565N1
Registration date:2019-04-23, 1398/02/03
Registration timing:retrospective
Last update:2019-04-23, 1398/02/03
Update count:0
Registration date
2019-04-23, 1398/02/03
Registrant information
Name
abbas روزبهانی
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3225 5678
Email address
a.rozbahani@iaurmia.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-01, 1397/04/10
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
2018-07-01, 1397/04/10
Actual recruitment end date
2018-11-25, 1397/09/04
Trial completion date
2018-11-28, 1397/09/07
Scientific title
Impact of hypothermia on final outcome of patients with acute stroke: a randomized clinical trial
Public title
Impact of cooling on patients with acute stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a hemorrhagic or ischemic stroke
Age over 18 years old
Informed consent form signed by the patient or his/her representative
Not having severe heart failure - Grade 2 and 3 based on cardiologist diagnosis
Absence of pulmonary embolism or acute myocardial infarction
Absence of any cardiac arrhythmia or ventricular or atrioventricular block in the ECG
Absence of acute or chronic sinusitis or current skull bone fracture
Not getting septicemia or bacteremia or severe blood infection at the admission time
Not having fever above 38.5 ° C when admitted
Absence of known blood diseases with increase the risk of thrombosis such as cryoglobulinemian, cold agglutination, or sickle cell anemia
Absence of known spastic venous complications, such as Raynaud's disease, or thromboangiitis obliterans
Weight less than 120 kg
Exclusion criteria:
Death in less than 24 hours after admission
Patient or legal guardian requisition for leaving the study
Incidence of unwanted side effects includes intolerance, seizure, shivering, or physician discretion
Incidence of cardiac dysrhythmias
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Cluster random sampling method will be used for sampling. Thus, from among 12 hospitals in Hamadan province, clusters from the internal and ICU wards will be randomly selected and the number of samples will be selected based on the number of hospitalized patients. Then, by simple random sampling method using by random numbers software, the samples will be assigned to the control and experimental groups and finally the samples of the two groups will be homogenized in terms of individual characteristics.
Blinding (investigator's opinion)
Single blinded
Blinding description
Hiding the allocation of patients to the control and test group Not knowing the executives and people involved in analyzing the data from the control and experimental groups
Placebo
Not used
Assignment
Parallel
Other design features
A study is a randomized controlled trial with control group. The intervention only is done on experimental group and the control group received routine treatment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Urmia Branch
Street address
Islamic Azad University., Urmia branch .,Salmas Road .,Orumieh
City
Orumieh
Province
West Azarbaijan
Postal code
5716963896
Approval date
2018-10-15, 1397/07/23
Ethics committee reference number
IR.IAU.URMIA.REC.1397.12
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G46
ICD-10 code description
Vascular syndromes of brain in cerebrovascular diseases
Primary outcomes
1
Description
level of patient alertness
Timepoint
A 72-hour period
Method of measurement
FOUR Score Scale: A tool that measures patient's alertness and level of consciousness.
2
Description
Predict the patient's recovery rate
Timepoint
A 72-hour period
Method of measurement
APACHE Scale that is used to measure the prognosis and recovery rate of the patients in critical care unit.
3
Description
Health level of patients
Timepoint
A 72-hour period
Method of measurement
The NIHSS scale a tool is used to health level of patients with stroke.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A, that hypothermia is performed through the cooling device (Helmets) which is placed on the patient's head.
Category
Treatment - Other
2
Description
Control group: Group B that patients receive routine care and no intervention is performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The research environment in this research is ICU wards of Hospitals affiliated to Hamadan University
Full name of responsible person
Abbas Rozbahani
Street address
Park Street, Islamic Azad University, Malayer Town
City
Hamadan
Province
Hamadan
Postal code
6571961441
Phone
+98 81 3222 0001
Fax
+98 81 3222 0471
Email
a.rozbahani@iaurmia.ac.ir
Web page address
http://shm.umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Zavari
Street address
Islamic Azad University of Urmia, Salmas road, Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
5716963896
Phone
+98 44 3272 2045
Fax
+98 44 3272 2045
Email
m.zavvari@iaurmia.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
50
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
Islamic Azad University
Full name of responsible person
Abbas Rozbahani
Position
Mentor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University of Urmia, Salmas road, Urmia Town
City
Uromieh
Province
West Azarbaijan
Postal code
5716963896
Phone
+98 44 3272 2045
Fax
+98 44 3272 2045
Email
abbas.rozbahanaa@yahoo.com
Web page address
http://shm.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Abbas Rozbahani
Position
Mentor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University of Urmia, Salmas road, Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
5716963896
Phone
+98 44 3272 2045
Fax
+98 44 3272 2045
Email
abbas.rozbahanaa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Abbas Rozbahani
Position
Mentor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University of Urmia, Salmas road, Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
5716963896
Phone
+98 44 3272 2045
Fax
+98 44 3272 2045
Email
abbas.rozbahanna@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Not disclosing private information of participants
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
The data is analyzed in the form of the SPSS software file by the statistical consultant. Patients names are be anonymous and the identification code is used for them. This data is kept confidential and is released from unauthorized persons.
When the data will become available and for how long
From April 2019
To whom data/document is available
Authorized individuals from Hamedan University of Medical Sciences and Islamic Azad University of Urumieh
Under which criteria data/document could be used
In order to develop research in the field of hypothermia
From where data/document is obtainable
Data is provided to the research deputy of Islamic Azad University of Urumieh
What processes are involved for a request to access data/document
Through an official application from the research deputy of Islamic Azad University of Urumieh
Comments
Research on the field of hypothermia by other researchers