Evaluation and comparison of the results of acute subdural hematoma evacuation by two methods of multidural stabs versus open dural flap
Design
The study is a randomized, community-based, and pragmatic clinical trial consisting of 60 patients in 2 parallel groups with double-blind design
Settings and conduct
This study will be carried out at Tabriz Imam Hospital in a two-blind manner,
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) patients aged 18 to 60 years
2) patients with Glasgow outcome score (GCS) lower or equal to 13
3) Patients with Acute subdural hematomas
Exit criteria: 1)Patient dissatisfaction 2). disorder such as brain aneurysm
3).existence of an bleeding disorder
Intervention groups
Intervention group Multi-Dural Stabs. parallel to the slippery vein of the vein 4-5 mm and 2-2.5 cm spacing between the hematoma lines will be evacuated.
Intervention group dural flap .flap surgery, expanded hemoptysis, and then duraplasty
Main outcome variables
Glasgow coma scale, Glasgow Outcome Scale, mortality rate, Brain herniation, Surgical site infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N12
Registration date:2020-01-20, 1398/10/30
Registration timing:registered_while_recruiting
Last update:2020-01-20, 1398/10/30
Update count:0
Registration date
2020-01-20, 1398/10/30
Registrant information
Name
Firooz Salehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0830
Email address
salehpourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the results of acute subdural hematoma evacuation by two methods of multidural stabs versus open dural flap
Public title
Evaluation two methods of multidural stabs and open dural flap on acute subdural hematoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 18 to 60 years
patients with Glasgow outcome score (GCS) lower or equal to 13
Patients with Acute subdural hematomas
Exclusion criteria:
Patient dissatisfaction
disorder such as brain aneurysm
existence of an bleeding disorder
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by last digit of the patient's file number . Even number for group open-dural flap and odd number for multi-dural stabs
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting study groups based on last digit of the patient's file number. 1 and 2 labels were assigned to the target group by the secretary. Then, the patients will be intervened by the researcher in the operating room in the case group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Medical School
Street address
Floor 3, Center building N 2, Tabriz university of medical sciences, Golgasht street.
City
Tabriz
Province
East Azarbaijan
Postal code
04133357310
Approval date
2019-12-23, 1398/10/02
Ethics committee reference number
IR.TBZMED.REC.1398.1049
Health conditions studied
1
Description of health condition studied
Traumatic subdural haemorrhage
ICD-10 code
S06.5X
ICD-10 code description
Traumatic subdural hemorrhage
Primary outcomes
1
Description
Disability Rating Scale (DRS) scoring
Timepoint
daily until discharge
Method of measurement
Disability Rating Scale questionnaire
2
Description
Glasgow Outcome Scale
Timepoint
daily until discharge
Method of measurement
Glasgow Outcome Scale questionnaire
Secondary outcomes
1
Description
Brain herniation
Timepoint
During 6 months after surgery
Method of measurement
Recurrent signs and symptoms of the patient and radiologic evidences on MRI
2
Description
Surgical site infection
Timepoint
2 days, 2 weeks, 3 months and 6 months after intervention
Method of measurement
physical examination, ESR and CRP lab tests
3
Description
mortality rate
Timepoint
In duration 6 weeks after traumatic brain injury
Method of measurement
Questionnaire on complications after traumatic brain injury
Intervention groups
1
Description
Intervention group1: Multi-Dural Stabs. parallel to the slippery vein of the vein 4-5 mm and 2-2.5 cm spacing between the hematoma lines will be evacuated.
Category
Treatment - Surgery
2
Description
Intervention group: dural flap .flap surgery, expanded hemoptysis, and then duraplasty
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurosurgery Ward of Emem Reza hospital
Full name of responsible person
Hossein Hamadani
Street address
Azadi St. Golghast St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
hosseinhamadani@gmail.com
Web page address
https://imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Street address
Azadi St., Golghast Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 3176
Email
Meshkinia@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?