Comparison of efficiency and safety of rivaroxaban and subcutaneous enoxaparin in the prevention of venous thromboembolic events after spinal instrumentation surgery
Comparison of efficiency and safety of rivaroxaban and subcutaneous enoxaparin in the prevention of venous thromboembolic events after spinal instrumentation surgery
Design
A randomized, double-blind, controlled clinical trial
Settings and conduct
Patients undergoing spinal surgery referring to the Imam Reza Hospital in Tabriz City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through block randomization. This trial will be double-blinded so that neither the treatment assessor nor the data analyzer will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients who have undergone spine surgery and have no previous history of venous thromboembolism.Exclusion criteria: Patient dissatisfactionsm , patients with coagulation disorders, People with underlying diseases such as high blood pressure, diabetes and severe osteoporosis , Patients with kidney failure
Intervention groups
Intervention group1: People who receive oral Rivaroxaban (Aboreihan Company) 10 mg twice a day after surgery for one week; Intervention group 2: people who receive subcutaneous Enoxaparin (Tehran Chemical Company) 40 mg daily for one week after surgery.
Main outcome variables
Inflammation, pain, differences in organ size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N16
Registration date:2023-07-22, 1402/04/31
Registration timing:registered_while_recruiting
Last update:2023-07-22, 1402/04/31
Update count:0
Registration date
2023-07-22, 1402/04/31
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
2023-07-06, 1402/04/15
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficiency and safety of rivaroxaban and subcutaneous enoxaparin in the prevention of venous thromboembolic events after spinal instrumentation surgery
Public title
Efficiency of rivaroxaban and enoxaparin in the prevention of venous thromboembolic events
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have undergone spine surgery and have no previous history of venous thromboembolism .
Exclusion criteria:
Patient dissatisfactionsm
patients with coagulation disorders
People with underlying diseases such as high blood pressure, diabetes and severe osteoporosis
Patients with kidney failure
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, individuals were assigned to two groups using the permutation block method(without replacement). In this method, A represents the individual receiving the rivaroxaban and B represents the individual in the subcutaneous enoxaparin group. Considering the quadruple block; they were classified into AABB, ABAB, ABBA, BAAB BBAA, and BABA permutations, and by random selection from permutation, patients were classified.
Blinding (investigator's opinion)
Double blinded
Blinding description
The randomization will be concealed using a sealed envelope prior to the start of the study, and the evaluator and the statistical analyst will be completely blind to the process. Upon arrival, individuals will be assigned to either the rivaroxaban or the subcutaneous enoxaparin group based on the letters A and B in their packet. the therapist, in the absence of evaluators, will provide the desired treatment based on the letter in the packet. In order to allocate concealment, the type of intervention will be written on paper and placed in matte, and packed envelopes.
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
5159115705
Approval date
2023-01-09, 1401/10/19
Ethics committee reference number
IR.TBZMED.REC.1401.917
Health conditions studied
1
Description of health condition studied
Spinal fusion
ICD-10 code
M99.3
ICD-10 code description
Osseous stenosis of neural canal
Primary outcomes
1
Description
Inflammation
Timepoint
after surgery daily for 10 days
Method of measurement
Clinical evaluation
2
Description
pain
Timepoint
after surgery daily for 10 days
Method of measurement
Clinical evaluation
3
Description
Differences in organ size
Timepoint
after surgery daily for 10 days
Method of measurement
Clinical evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People who receive oral Rivaroxaban (Aboreihan Company) 10 mg twice a day after surgery for one week.
Category
Treatment - Drugs
2
Description
Control group: people who receive subcutaneous Enoxaparin (Tehran Chemical Company) 40 mg daily for one week after surgery.
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
salamia871@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
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
Title and more details about the data/document
A portion of the data that represents the final outcome
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data of this study will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
For modeling and guidance
From where data/document is obtainable
The person responsible for updating study information
What processes are involved for a request to access data/document
The applicant provides information about their application via email. Up to two weeks after the request, if accepted, documents or data files will be sent.