A clinical trial to comparison of the Injury Severity Score (ISS) between cannabis, opium, and benzodiazepine consumption and healthy individuals in patients with head trauma
Objective: Effectiveness of the Injury Severity Score (ISS) between cannabis, opium, and benzodiazepine consumption and healthy individuals in patients with head trauma.
Design: A not blinded, block randomized clinical trial.
Study population: Patients with head trauma are referring to Shahid Hashemi Nezhad Hospital in Mashhad.
Inclusion criteria: Patients with head trauma are referring to Shahid Hashemi Nezhad Hospital in Mashhad; Glasgow Coma Scale (GCS) between 9 to 13.
Exclusion criteria: Patients who not consent to measure the specific substance urinary levels; patient with anuria; patient with shock.
Sample size: 75 cases.
Study intervention: Evaluation of cannabis, opium, and benzodiazepine urinary levels with immunochromatography and the Injury Severity Score (ISS) with questionnaire in healthy individuals and cannabis, opium, and benzodiazepine consumption with head trauma.
Study outcome: Evaluation and comparison of the Injury Severity Score (ISS) between cannabis, opium, and benzodiazepine consumption and healthy individuals in patients with head trauma.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100514872N3
Registration date:2016-11-06, 1395/08/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-11-06, 1395/08/16
Registrant information
Name
Mohammad Davood Sharifi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
sharifimd@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to comparison of the Injury Severity Score (ISS) between cannabis, opium, and benzodiazepine consumption and healthy individuals in patients with head trauma
Public title
The Injury Severity Score (ISS) in patients with head trauma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients with head trauma are referring to Shahid Hashemi Nezhad Hospital in Mashhad; Glasgow Coma Scale (GCS) between 9 to 13.
Exclusion criteria: Patients who not consent to measure the specific substance urinary levels; patient with anuria; patient with shock.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-02-22, 1393/12/03
Ethics committee reference number
IR.MUMS.REC.1393.954
Health conditions studied
1
Description of health condition studied
Patients with head trauma
ICD-10 code
S09.9
ICD-10 code description
Unspecified injury of head
Primary outcomes
1
Description
Cannabis, opium, and benzodiazepine urinary levels
Timepoint
After refer to hospital
Method of measurement
Immunochromatography
Secondary outcomes
1
Description
Injury Severity Score (ISS)
Timepoint
After refer to hospital
Method of measurement
Questionnaire
Intervention groups
1
Description
Control group: Evaluation of cannabis, opium, and benzodiazepine urinary levels with immunochromatography and the Injury Severity Score (ISS) with questionnaire in healthy individuals with head trauma.
Category
Diagnosis
2
Description
Intervention group: Evaluation of cannabis, opium, and benzodiazepine urinary levels with immunochromatography and the Injury Severity Score (ISS) with questionnaire in cannabis, opium, and benzodiazepine consumption with head trauma.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Hashemi Nezhad Hospital
Full name of responsible person
Elham Masomzade
Street address
Shahid Hashemi Nezhad Hospital, Tolab, Shahid Mofateh Avenue, end of Abooreihan Boulevard
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vawoud Sharifi
Position
Emergency Medicine
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3852 5312
Fax
Email
sharifimd@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dawoud Sharifi
Position
Emergency Medicine
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3852 5312
Fax
Email
sharifimd@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Masomzade
Position
Emergency Medicine
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3878 3917
Fax
Email
elham_em1218@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)