Survey of Low-dose Heparin, Enoxaparin and Rivaroxaban as Prophylaxis against Venous Thromboembolism in Moderate to Severe Traumatic Brain Injury: A Randomized Clinical Trial Study
Determining the preventive effect of enoxaparin, heparin and rivaroxaban drugs on venous thromboembolic events in patients with moderate to severe traumatic brain injury
Design
An uncontrolled clinical trial, parallel-group, triple-blind, randomized, phase 2، on 60 patients. Six permutation blocks will be used for randomization.
Settings and conduct
Basic characteristics and history of diseases are recorded. Patients are prescribed the first dose of heparin, enoxaparin and rivaroxaban after 48 hours from the time of trauma in Imam Reza (AS) Birjand Hospital. CT scan of the brain will be performed six hours after administration of the first dose of drug prophylaxis and then on day 4 and then before discharge. The anticonvulsant will be levotirastam. Lower Doppler ultrasound will be performed within 24 hours of admission and also at the time of discharge or ten days after the trauma.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients aged 16 to 70 with non-penetrating head trauma
Exclusion criteria:
Patients who have any type of coagulopathy and do not have the conditions to receive anticoagulants
Intervention groups
1- Heparin recipient group 2- Enoxaparin receiving group 3- Rivaroxaban recipient group
Main outcome variables
1-Age 2-sex 3-Weight 4-Type of prescription drug 5-Mechanism of head injury
6-GCS before admission 7-GOS 8-Vital signs 9-AIS 10Hospitalization period
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230705058684N1
Registration date:2023-08-01, 1402/05/10
Registration timing:prospective
Last update:2023-08-01, 1402/05/10
Update count:0
Registration date
2023-08-01, 1402/05/10
Registrant information
Name
Mohammadhosain Afrand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3721 7280
Email address
hosain.afrand@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-04-03, 1403/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of Low-dose Heparin, Enoxaparin and Rivaroxaban as Prophylaxis against Venous Thromboembolism in Moderate to Severe Traumatic Brain Injury: A Randomized Clinical Trial Study
Public title
Low-dose Heparin, Enoxaparin and Rivaroxaban as Prophylaxis against Venous Thromboembolism in Moderate to Severe Traumatic Brain Injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to Severe Traumatic Brain Injury
Age between 16 and 70
Latency time between injury and entering the study of less than 6 h
Without history of coagulopathy
Caprini Score of 3 or greater
Closed head injury
Glasgow Coma Scale (GCS) between 3 and 13
AIS (Abbreviated Injury Score 3 or less than 3
Exclusion criteria:
Age
From 16 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation is done using 6 permutation blocks, individually and by a sealed envelope.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Due to the low level of consciousness, the patients do not know about the type of medicine they received (due to the fact that all three drugs are common in preventing the intended outcome in the study, it does not create a problem from an ethical point of view). According to the randomization of the sampling of 6 substitution type, the healthcare personnel and the doctor in charge of the patient are not involved in the choice of medicine and are blinded. The person in charge of data collection did not interfere in the selection of the drug for the reasons mentioned, and blinding was done.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Lower Doppler ultrasound will be performed within 24 hours of admission to determine the presence of DVT before or at the time of admission, as well as at the time of discharge or ten days after trauma (the highest incidence of thromboembolism in trauma patients) or based on the indication and diagnosis of the therapist (in case of suspicion of thromboembolism based on symptoms). DVT diagnosis will be done with Doppler ultrasound and with ultrasound of the popliteal, saphenous, femoral and iliac veins.
Method of measurement
DVT diagnosis will be done with Doppler ultrasound and with ultrasound of the popliteal, saphenous, femoral and iliac veins.
2
Description
PE
Timepoint
Diagnosis of PE will be done with spiral CT angiography of the lungs and if indicated.
Method of measurement
Spiral CT angiography of the lungs
Secondary outcomes
1
Description
Glasgow coma scale between 3 and 13
Timepoint
Daily
Method of measurement
Clinical condition of the patient
2
Description
Intracranial Hematoma
Timepoint
According to the clinical presentation
Method of measurement
Brain CT- Scan
Intervention groups
1
Description
Intervention group: Heparin receiving group
Category
Prevention
2
Description
Intervention group: Enoxaparin receiving group
Category
Prevention
3
Description
Intervention group: Rivaroxaban receiving group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza (AS) Hospital
Full name of responsible person
Mohammadhosain Afrand
Street address
Taleghani
City
Birjand
Province
South Khorasan
Postal code
8917145438
Phone
+98 56 3162 4000
Email
Hosain.afrand@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Reza Miri
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
8917145438
Phone
+98 56 3238 1200
Email
miri_moh۲۵۱۶@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mohammadhosain Afrand
Position
Resident of Neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Taleghani
City
Birjand
Province
South Khorasan
Postal code
8917145438
Phone
+98 35 3723 7280
Email
Hosain.afrand@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammadhosain Afrand
Position
Resident of neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Taleghani
City
Birjand
Province
South Khorasan
Postal code
8917145438
Phone
+98 35 3721 7280
Fax
Email
Hosain.afrand@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammadhosain Afrand
Position
Resident of neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Taleghani
City
Birjand
Province
South Khorasan
Postal code
8917145438
Phone
+98 35 3721 7280
Fax
Email
Hosain.afrand@yahoo.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
All data is potentially shareable after de-identifying individuals
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 will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
All statistical information will be available without limitation