This study is conducted as a clinical trial without blinding, in which a lumbar drain is inserted in the case group, but it is not used in the control group. Patients are randomly divided into two groups in parallel groups. Randomizer software is used for randomization.
Settings and conduct
This study is conducted as a clinical trial without blinding, in which a lumbar drain is inserted in the case group, but it is not used in the control group. Patients are randomly divided into two groups in parallel groups. Randomizer software is used for randomization.
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients who suffer severe spinal cord injury following trauma (according to Asian classification in groups A, B, and C) Consent to participate in the study.
exclusion criteria: Age less than 18 years Lack of patient consent to enter the study No infection Penetrating trauma to the spine Having infiltrative diseases such as metastasis to the spine Presence of factors preventing MRI such as cardiac pacemaker Congenital disorders of the spine Previous history of spine surgery
Intervention groups
Case group: A drain is inserted for patients within the first 12 hours after referral and before performing lumbar surgery.
Control group: patients are operated without lumbar drain insertion.
Main outcome variables
Sensory and motor disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221108056446N3
Registration date:2023-07-27, 1402/05/05
Registration timing:prospective
Last update:2023-07-27, 1402/05/05
Update count:0
Registration date
2023-07-27, 1402/05/05
Registrant information
Name
Mehdi Mahmoodkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 686 3733
Email address
mahmoodkhani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using lumbar drain in patients with spinal cord injury
Public title
lumbar drain in patients with spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who suffer severe spinal cord injury following trauma (according to Asian classification in groups A, B, and C)
Consent to participate in the study.
Exclusion criteria:
Age less than 18 years
Lack of patient consent to enter the study
No infection
Penetrating trauma to the spine
Having infiltrative diseases such as metastasis to the spine
Presence of factors preventing MRI such as cardiac pacemaker
Congenital disorders of the spine
Previous history of spine surgery
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
People are placed in 2 groups by random block method.
In this way, the first 2 eligible people are selected and after obtaining consent, they enter to participate in the study. These 2 people are considered as a block of 2 and are sorted according to the last digit of the national code. The treatment methods are specified as A, B, and all combinations of 2 are specified, and after the last surgery, decoding is done for the last block.
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
Isfahan University of Medical Sciences
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-07-18, 1402/04/27
Ethics committee reference number
IR.MUI.MED.REC.1402.158
Health conditions studied
1
Description of health condition studied
spinal cord injury
ICD-10 code
G95.8
ICD-10 code description
Other specified diseases of spinal cord
Primary outcomes
1
Description
Sensory, motor disorder
Timepoint
Patients are examined one month, three months, six months and twelve months after lumbar drain placement.
Method of measurement
Clinical examination of the patient and force measurement of limbs
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For this group, a drain is inserted within the first 12 hours after referral and before lumbar surgery.
Category
Treatment - Devices
2
Description
Control group: Lumbar drain is not inserted in this group before surgery.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Mehdi Mahmoodkhani
Street address
Kashani Hospital
City
Isfahan
Province
Isfehan
Postal code
83434-81839
Phone
+98 31 3233 0091
Email
kashani@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Esfahan University of Medical Sciences
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
kashani street
City
Esfahan
Province
Isfehan
Postal code
83434-81839
Phone
+98 31 3233 0091
Email
mahmoodkhani@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Mahmoodkhani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Kashani street
City
Isafahan
Province
Isfehan
Postal code
83434-81839
Phone
+98 31 3233 0091
Email
mahmoodkhani@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Dashtian
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Kashani street
City
Isfahan
Province
Isfehan
Postal code
83434-81839
Phone
+98 31 3233 0091
Email
dashtian_hamid@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available