Effect of Intracranial Pressure Monitoring on Clinical Outcome and Mortality in Patients With Severe Traumatic Brain Injury
Design
The study will be double blind and clinical trial.120 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients With Severe Traumatic Brain Injury in Valiasr Hospital in Arak are divided into 2 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with head trauma, systolic pressure above 90 mm Hg, 18 years and above
Exclusion criteria:Death in the first 48 hours, mydriaz winx pupils are bilateral,
Dissatisfaction
Intervention groups
Intervention group: The ICP monitoring device will be used for the participants in the intervention group. Patients will undergo intracranial pressure monitoring surgery within 6 hours of admission.
Control group: routine treatment measures are performed based on the guideline "Dealing with severe head trauma patients 2007".
Main outcome variables
Glasgow Outcome Scale, mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N180
Registration date:2023-01-01, 1401/10/11
Registration timing:prospective
Last update:2023-01-01, 1401/10/11
Update count:0
Registration date
2023-01-01, 1401/10/11
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
2023-01-20, 1401/10/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intracranial Pressure Monitoring on Clinical Outcome and Mortality in Patients WithSevere Traumatic Brain Injury
Public title
Effect of Intracranial Pressure Monitoring on Clinical Outcome and Mortality in Patients WithSevere Traumatic Brain Injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with head trauma
Systolic pressure above 90 mm Hg
18 years and above
Exclusion criteria:
Death in the first 48 hours
Mydriaz winx pupils are bilateral
Dissatisfaction
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2021-12-26, 1400/10/05
Ethics committee reference number
IR.ARAKMU.REC.1400.282
Health conditions studied
1
Description of health condition studied
Severe Traumatic Brain Injury
ICD-10 code
S06.1X7
ICD-10 code description
Traumatic cerebral edema with loss of consciousness of any duration with death due to brain injury prior to regaining consciousness
Primary outcomes
1
Description
Glasgow Outcome Scale
Timepoint
Afetr intervention
Method of measurement
Glasgow Questionnaire
2
Description
Mortality
Timepoint
Afetr intervention
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The ICP monitoring device will be used for the participants in the intervention group. Patients will undergo intracranial pressure monitoring surgery within 6 hours of admission.
Category
Treatment - Surgery
2
Description
Control group: routine treatment measures are performed based on the guideline "Dealing with severe head trauma patients 2007".
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Alireza Mohammadi
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
nazemi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mahdi Salehi
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
solhi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?