Determining the effect of head cooling and conditioning ischemia in patients with traumatic brain injury
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 84 patients.
Settings and conduct
A brain disorder caused by an external force applied to the head is known as a traumatic brain injury. Traumatic brain injuries are primary and secondary. Primary injury occurs immediately after the main injury and trauma, which includes bruising, damage to blood vessels, and axonal amputation, in which the axons of neurons are actually stretched or torn. Secondary injuries include damage to the blood-brain barrier, release of factors that lead to inflammation, overload of free radicals, excessive release of the neurotransmitter glutamate, entry of calcium and sodium ions into neurons, and mitochondrial dysfunction. The inflammatory response is initiated and controlled by a range of pre-inflammatory and anti-inflammatory cytokines, which are among the inseparable features of traumatic brain injury. Some studies have shown that interleukin-10 levels rise in severe traumatic brain injury. The level of alpha tumor necrosis factor in cerebrospinal fluid and serum of patients with traumatic brain injury increases. The usual clinical goal in traumatic brain injury is to reduce body temperature to normal.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age must be between 14 and 65 years and the Glasgow Coma Scale score of less than 8 ones are transferred to the intensive care unit.
Exclusion criteria: drug dependence or history of cognitive impairment
Intervention groups
1) Head cooling group
2) RIC technique group
3) Head cooling group and RIC technique
Main outcome variables
Determining the average APACHE II scores in different study groups before and after the study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210209050307N1
Registration date:2021-03-13, 1399/12/23
Registration timing:prospective
Last update:2021-03-13, 1399/12/23
Update count:0
Registration date
2021-03-13, 1399/12/23
Registrant information
Name
Amir Moghadamahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 3328
Email address
a.moghadamahmadi@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2030-07-06, 1409/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Head Cooling and Remote Conditioning in Limb on outcome of patients with Traumatic Brain Injury
Public title
Effect of Head Cooling and Remote Conditioning in Traumatic Brain Injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Glawsco Coma Scale (GCS) score of less than 8
Exclusion criteria:
presence of known inflammatory disorder
history of neurological or psychological disorders
dependence to drugs or opium
mild Traumatic Brain Injury (TBI)
signs of disseminated injury without mass effect on brain Computed Tomography (CT) scan image
Age
From 14 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Patients enter the groups randomly after visiting the emergency department. Patients who enter the hospital consecutively enter the study groups in order. Randomization is block type and people enter the hospital in the first, second, third or fourth block, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
After diagnosing the disease, the treating physician does not know the patient's entry into the desired group and the type of treatment, and also the patient has no information about the intervention and treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Emam Ali street
City
Rafsanjan
Province
Kerman
Postal code
7719794454
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.RUMS.REC.1395.138
Health conditions studied
1
Description of health condition studied
Traumatic Brain Injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
APACHE II scores
Timepoint
72 hours -6 days- 2 months later
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: There is no intervention on them
Category
Diagnosis
2
Description
Intervention group 2: Head cooling group: Hypothermia caps are usually made of synthetic materials such as neoprene, silicone or polyurethane and are cooled with a cooling agent such as ice and gel that can be cooled to -25 to -30 degrees Celsius before use. For repeated use of the caps, they are filled with krillon gel, which freezes up to -30 degrees Celsius. As the caps warm up during use, several ice caps are prepared, which must be replaced with a new, completely frozen ice cap every 20 to 30 minutes after use. In groups with ice caps, treatment is started immediately after admission. It is used for the first three consecutive days after admission for 0 to 6 hours (average 4.5 hours) depending on the patient's condition and tolerance to maintain the brain temperature at 33 to 34 degrees Celsius. The researcher measures the temperature of the brain with a tympanic membrane thermometer (the difference between the temperature of the tympanic membrane and the temperature of the brain is about 0.2 degrees Celsius). For this purpose, the brain temperature is likely to drop to about 33 to 34 degrees Celsius (it takes about 2 hours) and is maintained in the same range.
Category
Treatment - Devices
3
Description
Intervention group 3: RIC Technique Group: Arm ischemia is a full 5-minute full blood pressure cuff and a 5-minute empty blood pressure cuff in which the cuff is filled to 200 mm Hg or the patient's systolic pressure plus 25 mm Hg. This will be done at the same time as putting on the ice cap in the golden hours after the injury
Category
Treatment - Other
4
Description
Intervention group 4: Head cooling group and RIC technique
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abitaleb Hospital
Full name of responsible person
Fardin Hodoodi
Street address
Ali Ibn Abitaleb Square
City
Rafsanjan
Province
Kerman
Postal code
7719794454
Phone
+98 34 3428 0000
Email
fardin.neurosurgeon@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Abozar1/1
City
Rafsanjan
Province
Kerman
Postal code
7719794454
Phone
+98 34 3428 0086
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Amir moghadamahmadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Abozar 1/1
City
Rafsanjan
Province
Kerman
Postal code
7719794454
Phone
+98 34 3423 4191
Email
a.moghadamahmadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
a.moghadamahmadi@gmail.com
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
abozar1/1
City
Rafsanjan
Province
Kerman
Postal code
7719794454
Phone
+98 34 3423 4191
Email
a.moghadamahmadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Amir moghadamahmadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
abozar 1/1
City
Rafsanjan
Province
Kerman
Postal code
7719794454
Phone
+98 34 3423 4191
Email
a.moghadamahmadi@gmail.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