Protocol summary

Study aim
prophylactic intravenous or oral levetiracetam and phenytoin in delay post trauma seizure
Design
The present study is a randomized controlled trial study of double-blind control.The target population of this study is patients who complain of head trauma to the hospital and are candidates for anticonvulsant prophylaxis and express their consent to participate in the trial in writing. Criteria for initiating anticonvulsant prophylactic treatment for patients based International Classi ation cation of Diseases, Ninth Revision, Clinical Modi fi cation (ICD-9-CM) is. In each group, 60 patients will be randomly assigned.
Settings and conduct
The study will be conducted at Al-Zahra and Kashani Hospitals in Isfahan, where patients with traumatic brain injury are randomly divided into two groups and are treated with medication.
Participants/Inclusion and exclusion criteria
entry criteria; Head trauma that requires antiretroviral prophylaxis treatment, for example, the patient has hypertensive depression or intracerebral hemorrhage. The patient must be at least 18 years old exit criteria: Pregnancy, Previous history of epilepsy, Previous history of seizures after trauma to the head, Sensitivity, Late visit to the hospital 12 hours after the trauma
Intervention groups
The intervention group in this technical trial of Twain is treated with a loading dose of 20mg/kg and injection within one hour and a maintenance dose of 5 mg/kg/day, which the patient first receives for 24 to 48 hours after the injection and then orally. The control group is treated with lootirastam with a loading dose of 20mg/kg and injection within one hour and a maintenance dose of 10-20 mg/kg/day, which the patient first receives for 24 to 48 hours and then oral administration.
Main outcome variables
Late seizures

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200415047090N1
Registration date: 2020-07-26, 1399/05/05
Registration timing: registered_while_recruiting

Last update: 2020-07-26, 1399/05/05
Update count: 0
Registration date
2020-07-26, 1399/05/05
Registrant information
Name
Saeid Saghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3624 6796
Email address
saeidsaghaei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prophylactic intravenous or oral levetiracetam and phenytoin in delay post trauma seizure
Public title
prophylactic intravenous or oral levetiracetam and phenytoin in delay post trauma seizure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Head trauma that requires antiretroviral prophylaxis treatment, for example, the patient has hypertensive depression or intracerebral hemorrhage (IntraCerebral Hemorrhage, Intraventricular hemorrhage,Subarachnoid hemorrhage). The patient must be at least 18 years old Sign a written consent to participate in the study
Exclusion criteria:
Pregnancy Previous history of epilepsy Previous history of seizures after trauma to the head Taking other anticonvulsant drugs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign patients, a randomized block allocation method with a volume of 4 patients in each block will be used. The third person independent of the study, based on the random block method, provides a list of 160 randomly coded codes and provides it to the research team along with 160 coded envelopes. Eligible patients enter the list and, based on the numerical code listed in the envelope list, open the code that corresponds to the numeric code listed in the list and inject the encoded drug into the patient.
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 Esfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib St., Shiraz Gate,
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2020-05-30, 1399/03/10
Ethics committee reference number
IR.MUI.MED.REC.1398.501

Health conditions studied

1

Description of health condition studied
Head traumatic injury
ICD-10 code
G44.3
ICD-10 code description
Post-traumatic headache

Primary outcomes

1

Description
Intracranial hemorrhage
Timepoint
7 day
Method of measurement
Patient seizures and other clinical symptoms

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Phenytoin is treated with a loading dose of 20 mg / kg and injection within one hour and a maintenance dose of 5 mg / kg / day, which the patient first receives for 24 to 48 hours after injection and then orally.
Category
Treatment - Drugs

2

Description
Control group: Lothirastam is treated with a 20 mg / kg loading and injection within an hour and a maintenance dose of 10-20 mg / kg / day, which the patient first receives for 24 to 48 hours after the injection and then orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Dr Mehdi Shafiei
Street address
Al-Zahra Educational and Medical Center, Al-Safa Boulevard
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Mehdishafiei82@gmail.com

2

Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Dr Mehdi Shafiei
Street address
Kashani Ave, Kashani Hospital
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
Dr Shaghayegh Haghjoe Javanmard
Street address
Isfahan University of Medical Sciences, Hezar Jarib St., Shiraz Gate,
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
alzahra@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
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
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 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 Saeid Saghaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.,
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3668 0048
Email
SaeidSaghaei@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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