The effect of topical corticosteroids combined with surgery in patients with chronic subdural hematoma
Design
Randomized clinical trial on 30 patients, without control group, phase 2
Settings and conduct
On the third day after the operation, after monitoring the drain discharge, the drain is removed and before removing the drain, 40 mg of methylprednisolone sodium succinate is injected through the drain into the hematoma drainage chamber and the drain is completely removed.
All patients referred to Ahvaz medical university hospitals with chronic subdural hematoma
Main outcome variables
Change in headache symptoms, change in postoperative seizure symptoms, change in postoperative paresis symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200911048685N1
Registration date:2021-02-21, 1399/12/03
Registration timing:registered_while_recruiting
Last update:2021-02-21, 1399/12/03
Update count:0
Registration date
2021-02-21, 1399/12/03
Registrant information
Name
Davood Mahmoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3372 8265
Email address
mahmoudi.d@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2021-04-21, 1400/02/01
Trial completion date
2021-04-21, 1400/02/01
Scientific title
The effect of topical corticosteroids combined with surgery in patients with chronic subdural hematoma
Public title
corticosteroids in chronic subdural hematoma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
chronic subdural hematoma
Exclusion criteria:
Acute subdural hematoma
traumatic ICH
Epidural hematoma
depress fx
Intracranial mass and lesions
open lesion
CSF leak
previous shunt
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
15
Randomization (investigator's opinion)
Not 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 Ahvaz jundishapur univercity of medical sciences
Street address
Golestan, jundishapur university of medical sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715753
Approval date
2020-10-27, 1399/08/06
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.086
Health conditions studied
1
Description of health condition studied
chronic SubDural hematoma
ICD-10 code
I62.03
ICD-10 code description
Nontraumatic chronic subdural hemorrhage
Primary outcomes
1
Description
Recurrence of chronic subdural hemorrhage
Timepoint
6 months
Method of measurement
Designed questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A cross-sectional study will be performed on patients who have referred to hospitals related to Ahvaz University of Medical Sciences during subdural hematoma during 1398. Accordingly, after presenting the plan in the form of a research proposal and approving it in the relevant committees, the researcher, after receiving a license from Ahvaz Jundishapur University of Medical Sciences and a letter of introduction from the Vice Chancellor for Research and Technology, sampled based on the study process. And inclusion and exclusion criteria, in such a way that the goals and process of the study were stated as needed for patients, patients or patients' companions are asked to read and sign the informed consent form for the study and then patients enter Are studied. Accordingly, patients requiring surgical evacuation of subdural chronic hematoma who met the inclusion and exclusion criteria after nude craniotomy on the hematoma and drainage and rinsing of the hematoma with Ringer's serum implant a drain in the nostril of the craniotomy and the patient after surgery. The surgery is transferred to the neurosurgery department and monitored. On the third day after the operation, after monitoring the discharge of the drain, the drain is pulled and before removing the drain, 40 mg of methylprednisolone succinate is injected through the drain into the hematoma drain chamber. And the drain is completely stretched.
Category
Treatment - Drugs
2
Description
Control group: Distilled water is used for this group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Hossein Safari
Street address
Golestan st. unishapur Ahvaz university of medical sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715753
Phone
+98 61 3333 0074
Email
davood.mahmoudi68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammade Badavi
Street address
Golestan sreet.jondishapour univercity medical of science
City
Ahvaz
Province
Khouzestan
Postal code
6135715753
Phone
+98 61 3333 0074
Fax
+98 61 3333 2036
Email
Davood.mahmoudi68@gmail.com
Grant name
Ahvaz Univercity Of Medical Sience
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hossein Safari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Golestan Street.North Esfand Street
City
Ahwaz
Province
Khouzestan
Postal code
6135715753
Phone
+98 61 3333 0074
Email
Davood.mahmoudi68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hossein Safari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Golestan Street,North Esfand
City
Aََhvaz
Province
Khouzestan
Postal code
6135715753
Phone
+98 61 3333 0074
Email
Mahmoudi.d@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hossein Safari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
North Esfand Ave, Golestan Ave
City
Ahwaz
Province
Khouzestan
Postal code
6135715753
Phone
+98 61 3333 0074
Email
Mahmoudi.d@ajums.ac.ir
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