Study the effect of computed tomography without contrast in management of patients after moderate traumatic brain injury in a randomized clinical trial
Determining the effect of computed tomography without contrast in management of patients after moderate traumatic brain injury
Design
Randomized Clinical Trial open-label
Settings and conduct
Patients referred to the emergency department of Vali-e-Asr Hospital in Fasa who meet the inclusion criteria are identified by the neurosurgeon and the objectives of the study are explained to the patient or companion and take their written consent. Patients are divided into intervention and control arms. Patients in both arms will be transferred to a neurosurgery ICU. For all patients at zero, a CT scan of the brain will be taken without contrast. Questionnaires are then completed by trained ICU nurses and neurosurgeons.
Participants/Inclusion and exclusion criteria
In this study, patients in the age range of 19 to 95 years who have been admitted to the emergency room of Hazrat Vali Asr Fasa Hospital due to brain trauma, will be included in the study with all the following conditions:
The patient is in the first 6 hours after the onset of symptoms
The patient was taken CT scan without contrast
Glasgow Coma Score scale The patient should be between 8 and 14
The patient is not a candidate for neurosurgical surgery
The patient's vital signs are completely stable without inotropic drugs
The patient is not pregnant
The patient has no seizures or no focal neurological deficit
Intervention groups
A follow-up CT routine will be performed for all patients 6 hours after the initial CT scan in the control arm. In the intervention arm, patients will have a follow-up CT scan at 6 hours after the initial CT based on the occurrence of each of the following four:
Any change in GCS
Change in pupil size by more than one millimeter
Change in the reaction of one or two pupils to light
The emergence of any new focal neurological deficit
Main outcome variables
Need for surgical interventions; Death
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210509051232N1
Registration date:2021-08-06, 1400/05/15
Registration timing:prospective
Last update:2021-08-06, 1400/05/15
Update count:0
Registration date
2021-08-06, 1400/05/15
Registrant information
Name
Adrina Habibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3835 5957
Email address
adrina.hbz77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of computed tomography without contrast in management of patients after moderate traumatic brain injury in a randomized clinical trial
Public title
the effect of computed tomography without contrast in management of patients after moderate traumatic brain injury
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is in the first 6 hours after the onset of symptoms
According to the PECARN criteria, the patient was taken without a brain contrast agent at the time of CT scan
Glasgow Coma Score scale of the patient should be between 8 and 14
The patient is not a candidate for neurosurgical surgery
The patient or his first-degree companion is willing to participate in the study consciously
The patient is not a candidate for emergency surgery from another service
The patient's vital signs are completely stable without the need for inotropic drugs
The patient is not pregnant
The patient does not have Anisocoria
The patient has no seizures or no focal neurological deficit
Exclusion criteria:
Glasgow Coma Score scale=3 and bilaterally fixed dilated pupils
From the beginning of the study, the patient may experience a drop in GCS
The need for neurosurgery or any other surgery at any time from the start of the study
The unwillingness of the patient or his first-degree companions to participate in the study
Lack of trust in the patient's neurological examination for any reason (psychologic cases, low compliance of the patient or companions, initiation of sedative drugs)
Perform a brain CT scan for any reason earlier than 6 hours after the initial CT scan
Previous use of anticoagulant drug
Age
From 19 years old to 95 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
After generating a random sequence using random allocation software. Patients with eligibility conditions were selected by convenience sampling and randomly divided into groups with and without follow-up CT scans by randomized 4-way permutation blocks. It should be noted that the list prepared with tags will be kept secret for hiding. Patients are divided into intervention and control arms.
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 committee of Fasa University of Medical Sciences
Street address
Ebne Sina Square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2021-08-03, 1400/05/12
Ethics committee reference number
IR.FUMS.REC.1400.045
Health conditions studied
1
Description of health condition studied
moderate traumatic brain injury
ICD-10 code
S06.9
ICD-10 code description
Unspecified intracranial injury
Primary outcomes
1
Description
Need for surgical intervention
Timepoint
6 hours and 30 day
Method of measurement
Patient file
Secondary outcomes
1
Description
Death
Timepoint
6 hours and 30 days
Method of measurement
patient file
2
Description
length of hospital stay
Timepoint
6 hours and 30 days
Method of measurement
patient file
Intervention groups
1
Description
Control group: Head CT scan without contrast routinely in all patients, In the control arm, a follow-up routine CT will be performed for all patients 6 hours after the initial CT scan. Also, all patients are admitted to the intensive care unit of neurosurgery and neurological examinations are performed every half an hour. Neurological examination includes Glasgow Coma Scale (GCS), pupil size, pupil light response, focal neurological deficit, vital signs, cerebral nerve examination 3, 4, 6, 10, and manual muscle test (MMT).
Category
Diagnosis
2
Description
Intervention group: Head CT scan without contrast, if the doctor decides, based on the patient's clinical condition, In the intervention arm, patients will have a follow-up CT scan at 6 hours after the initial CT based on the occurrence of each of the following four cases: 1. Any change in the Glasgow Coma Scale (GCS) 2. Change of more than one millimeter in pupil size (one or two-sided) 3. Change in the reaction of one or two pupils to light 4. The appearance of any new focal neurological deficit. Also, all patients are admitted to the intensive care unit of neurosurgery and neurological examinations are performed every half an hour. Neurological examination includes Glasgow Coma Scale (GCS), pupil size, pupil light response, focal neurological deficit, vital signs, cerebral nerve examination 3, 4, 6, 10, and manual muscle test (MMT).
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-asr hospital
Full name of responsible person
Reza Taheri
Street address
Ebne Sina Square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5331 5026
Email
Adrina.hbz77@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mojtaba Farjam
Street address
Ebne Sina Square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5331 5026
Email
Adrina.hbz77@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Adrina Habibzadeh
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid rajai str, Shiraz
City
Shiraz
Province
Fars
Postal code
7185935489
Phone
+98 71 3835 5957
Fax
Email
Adrina.hbz77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Adrina Habibzadeh
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid rajai str, Shiraz
City
Shiraz
Province
Fars
Postal code
7185935489
Phone
+98 71 3835 5957
Fax
Email
Adrina.hbz77@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Adrina Habibzadeh
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid rajai str, Shiraz
City
Shiraz
Province
Fars
Postal code
7185935489
Phone
+98 71 3835 5957
Fax
Email
Adrina.hbz77@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be published after being unidentifiable
When the data will become available and for how long
Information will be available without a time limit
To whom data/document is available
Qualified persons according to the publisher's rules
Under which criteria data/document could be used
For scientific use with detailed mention of the source
From where data/document is obtainable
Refer to Publisher / Contact via the author's email address
What processes are involved for a request to access data/document
Information can be provided after correspondence via academic email