Comparative efficacy of early and late term imitation of prophylactic enoxaparin in prevention of thrombotic event and prevalence of hemorrhagic complications in patients with chronic subdural hematoma treated with Burr-hole craniostomy approach
Comparative efficacy of early and late initiation of prophylactic enoxaparin in prevention of thrombotic event and prevalence of hemorrhagic complications in patients with chronic subdural hematoma treated with Burr-hole craniostomy approach
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
number of cases: two groups of 30 patients
Settings and conduct
This study was conducted in two medical centers in Al-Zahra and Kashani in Isfahan and the researcher and the patient are unaware of which group each patient is in.
the patients are grouped into 24 or 72-hour interval from operation-to-enoxaparin administration.then enoxaparin will be administered,all patients will be followed up with brain CT scan and both lower legs color Doppler ultrasonography
Participants/Inclusion and exclusion criteria
All people who are diagnosed with Chronic subdural haematoma undergoing surgery and are eligible to enter the study are included in the study, and those who are contraindicated in receiving onoxaparin or who refuse to enter the study are excluded from the study group.
Intervention groups
the patients are grouped into early and late-initiation interval from operation-to-enoxaparin administration.then enoxaparin will be administered in 24-hour or 72-hour after operation,all patients will be followed up with brain CT scan and both lower legs color Doppler ultrasonography
Main outcome variables
Bleeding events (epidural and cerebral hematoma)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200207046400N1
Registration date:2020-06-13, 1399/03/24
Registration timing:registered_while_recruiting
Last update:2020-06-13, 1399/03/24
Update count:0
Registration date
2020-06-13, 1399/03/24
Registrant information
Name
arman sourani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3447 2636
Email address
armansourani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of early and late term imitation of prophylactic enoxaparin in prevention of thrombotic event and prevalence of hemorrhagic complications in patients with chronic subdural hematoma treated with Burr-hole craniostomy approach
Public title
efficacy of early and late term imitation of prophylactic enoxaparin in prevention of thrombotic event and prevalence of hemorrhagic complications in patients with chronic subdural hematoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have been diagnosed with Chronic subdural haematoma who undergo surgical evacuation
Patient consent
Exclusion criteria:
contraindications to receive enoxaparin
occurrence of existence of deep venous thrombus in the period of study
existence of hematoma in post operative brain CT scan
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
the patients will be randomly allocated using statistical software.then they will be assigned into two major arms of study,early and late-enoxaparin administration.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, after explaining the goals to the patient, he is given informed consent. Patients are randomly divided into two groups, but neither group is aware of which group. The researcher does not know which group each patient belongs to. However, the clinical caregiver is aware of the group of patients and uses the drug in accordance with the group in which the patient is placed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.,
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Approval date
2020-01-21, 1398/11/01
Ethics committee reference number
IR.MUI.MED.REC.1398.664
Health conditions studied
1
Description of health condition studied
Chronic subdural haematoma
ICD-10 code
I62. 03
ICD-10 code description
Chronic subdural haematoma
Primary outcomes
1
Description
Bleeding events (epidural and cerebral hematoma)
Timepoint
24 , 72 hours after surgery by craniotomy
Method of measurement
Brain CT scan
2
Description
Thrombotic events
Timepoint
24 , 72 hours after surgery by craniotomy
Method of measurement
Double-sided Doppler ultrasound of the lower extremities
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Enoxaparin with a prophylactic dose 24 hours per day at a dose of 1 mg / kg (maximum 40 mg)
Category
Treatment - Drugs
2
Description
Control group: Enoxaparin with a prophylactic dose 72 hours per day at a dose of 1 mg / kg (maximum 40 mg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Arman Sourani
Street address
Al-Zahra hospital, Sofeh St.,Isfahan,Iran
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
armansourani@gmail.com
2
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Arman Sourani
Street address
Kashani ST
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3233 0091
Email
armansourani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjuye Javanmardi
Street address
Isfahan University of Medical Sciences, hezar jarib S.T
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
1
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Shafiei
Position
استادیار
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.,
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3668 0048
Email
Mehdishafiei82@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Shafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.,
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3668 0048
Email
Mehdishafiei82@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Shafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.,
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3668 0048
Email
Mehdishafiei82@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data can be shared after people become unrecognizable
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Just for study and new research people
From where data/document is obtainable
Email Author responsible:Mehdishafiei82@gmail.com
What processes are involved for a request to access data/document
in first step,the request should be sent to corresponding author .the reasons, affiliations and authenticity of request will be investigated by author.
then with concealing the personal data of patients due to privacy concerns and ethical issues, requested data will be available in following 2 weeks after appeal.