Evaluation of the effectiveness of aspirin in preventing (DVT) Deep Vein Thrombosis after lumbar spinal stenosisSurgeries
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 102 patients will be candidates for spinal stenosis decompression surgery. Excel software rand function will be used for randomization.
Settings and conduct
Patients over 40 years of age who are candidates for spinal stenosis decompression surgery who will refer to the orthopedic clinic of Shafa Yahyaian Hospital affiliated to Iran University of Medical Sciences will be included in the study. Sampling of patients is done by available and easy sampling. Patients are then randomly assigned to intervention and control groups. Patients will be blind to researchers and analyzers of the results of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: patients over 40 years of age, candidates for decompression of spinal canal stenosis and Informed consent to participate in the study. Exclusion criteria include: Prohibition of the use of aspirin and associated musculoskeletal disorders including severe osteoarthritis, rheumatoid arthritis, fibromyalgia.
Intervention groups
Intervention group: Patients who have undergone spinal stenosis decompression and will receive 325 mg oral aspirin twice a day for 2 to 4 weeks, and the control group includes patients who have undergone spinal stenosis decompression and received oral placebo. will do.
Main outcome variables
Incidence of DVT after lumbar spinal stenosis surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210825052290N1
Registration date:2021-12-06, 1400/09/15
Registration timing:prospective
Last update:2021-12-06, 1400/09/15
Update count:0
Registration date
2021-12-06, 1400/09/15
Registrant information
Name
Ali Habibollahzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3354 2041
Email address
alihabibollahzadeh.ortho@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of aspirin in preventing DVT after lumbar spinal stenosisSurgeries
Public title
The effectiveness of aspirin in preventing DVT after lumbar canal stenosis Surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over 40 years of age who have undergone decompression of spinal canal stenosis
Patients' informed consent
Exclusion criteria:
Prohibition of aspirin use
Concomitant musculoskeletal diseases including severe osteoarthritis, rheumatoid arthritis, fibromyalgia
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Random chain construction of two groups of 51 A (intervention group) and B (control group) using Excel software will be used. In a column of 51 letters A and 51 letters B and in the adjacent column with the Rand command, make 102 random numbers. Arrange both columns in random order from large to small. The sequence of letters A and B will be the random sequence used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are randomly assigned to intervention and control groups. In such a way that patients, the prescribing physician, and the analyzer will be blind to the groups that have received the drug or placebo.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-11-21, 1400/08/30
Ethics committee reference number
IR.IUMS.REC.1400.766
Health conditions studied
1
Description of health condition studied
Deep Vein Thrombosis
ICD-10 code
I82.4
ICD-10 code description
Acute embolism and thrombosis of deep veins of lower extremity
Primary outcomes
1
Description
Frequency of DVT after lumbar spinal stenosis
Timepoint
After the intervention and 3 months after taking aspirin
Method of measurement
Intravenous color Doppler ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Candidates for decompression stenosis surgery who will receive 325 mg oral aspirin twice daily for 3 weeks after surgery.
Category
Prevention
2
Description
Control group: Yamaran is a candidate for canal stenosis decompression surgery who will receive oral placebo twice a day for 3 weeks after surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyaian Hospital
Full name of responsible person
Ali Habibollahzadeh
Street address
Tehran, Baharestan Square, Mojahedin-e-Islam St., Shafayehiaian Educational and Medical Center
City
Tehran
Province
Tehran
Postal code
3713111576
Phone
+98 21 3354 2001
Email
alihabibollahzadeh.ortho@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Kiwani
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Ali Habibollahzadeh
Position
asistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Tehran, Baharestan Square, Mojahedin-e-Islam St., Shafayehiaian Educational and Medical Center
City
Tehran
Province
Tehran
Postal code
3713111576
Phone
+98 21 3354 2001
Email
alihabibollahzadeh.ortho@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohamadrez shakeri
Position
Asistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Tehran, Baharestan Square, Mojahedin-e-Islam St., Shafayehiaian Educational and Medical Center
City
Tehran
Province
Tehran
Postal code
3713111576
Phone
+98 21 3354 2001
Email
mshakeri3116@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Habibollahzadeh
Position
Asistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Tehran, Baharestan Square, Mojahedin-e-Islam St., Shafayehiaian Educational and Medical Center
City
Tehran
Province
Tehran
Postal code
3713111576
Phone
+98 21 3354 2001
Email
alihabibollahzadeh.ortho@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
Yes - There is a plan to make this available
Title and more details about the data/document
Unidentifiable personal data of participants will be shared upon request upon completion of the study. The protocol of surgery and study will be provided to the researchers in the form of a report after the end of the study. Statistical analysis of the data of this study will be shared in the form of a report after the end of the study. Informed design consent form, study clinical reports and codes used in the analysis will be shared in the form of a report at the end of the study. Part of the data, such as information about the main outcome or the like, will be published collectively without identifying individuals in the form of an article
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
University researchers
Under which criteria data/document could be used
Use to promote knowledge and researchers without permission to manipulate documents
From where data/document is obtainable
corresponding
What processes are involved for a request to access data/document
Send a written request and then review and if the request is approved, the documents will be delivered. (Maximum one month)