| CTRI Number |
CTRI/2023/11/060169 [Registered on: 22/11/2023] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing different medicines for preventing fits/seizures /convulsions in accident patients |
|
Scientific Title of Study
|
Comparison of phenytoin aand leveteracitam for prophylaxis of seizures in the early postoperative period in TBI patients-a pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zulfiqar Ali |
| Designation |
Additional Professor |
| Affiliation |
Sheri-I-Kashmir Institute of Medical sciences |
| Address |
Department of Anesthesia, Sher-I-kashmir institute of medical sciences, 190011
Srinagar
JAMMU & KASHMIR
190011
India |
| Phone |
9419086761 |
| Fax |
|
| Email |
zulfiqaraliiii@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zulfiqar Ali |
| Designation |
Additional Professor |
| Affiliation |
Sheri-I-Kashmir Institute of Medical sciences |
| Address |
Department of Anesthesia, Sher-I-kashmir institute of medical sciences, 190011
Srinagar
JAMMU & KASHMIR
190011
India |
| Phone |
9419086761 |
| Fax |
|
| Email |
zulfiqaraliiii@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Eman Aftab |
| Designation |
DrNB Neuroanesthesia and neurocritical care |
| Affiliation |
Shere-i-kashmir institute of medical sciences |
| Address |
Room 2A,near NeuroIcu,Skims,Soura,190001
Srinagar
JAMMU & KASHMIR
190001
India |
| Phone |
7006886034 |
| Fax |
|
| Email |
justme_eman@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sher-I-Kashmir Institute of medical sciences,Soura,Srinager,J and K,190001 |
|
|
Primary Sponsor
|
| Name |
Hospital supplyfree of cost Sherikashmir institute of medical sciences |
| Address |
Shere-e-kashmir institute of medical sciences,skims,Soura,190001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Zulfiqar Ali |
Sheri Kashmir Institute of medical Sciences Soura |
Room no 21. Old library
Division of Neuroanesthesia , Department of anesthesia .SOURA Srinagar
Srinagar
JAMMU & KASHMIR |
9419086761
zulfiqaraliiii@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shere-e-kashmir institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Leveteracetam |
Antiepileptic drug,
500mg BD,via intravenous route, for 7 days
|
| Comparator Agent |
Phenytoin |
Antiepileptic agent,
100mg TID, via intravenous route,
for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1)Pts 18yrs or above
2)Pts with diagnosis of TBI
3)GCS less than 8 |
|
| ExclusionCriteria |
| Details |
1)Pts with history of epilepsy or seizure disorder.
2)Pt with history of hypersensitivity or allergy to phenytoin or leviteracetam.
3)Pt with history of liver or kidney disease.
4)Pts who are pregnant or breast feeding.
5)Pts who don’t give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Time to first seizure
2)total seizures during 7 days
|
During 7 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
No. of days of icu stay.
No. of days of hospital stay |
Till patient is discharged. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Traumatic brain injury is one of the leading causes of death and disability through out the world .Occurance of seizures can worsen the outcome in these patients. Though TBI guidelines advocate the use of phenytoin for early onset seizures in TBI, there is emerging evidence that the use of the broad spectrum drugs as leveteracitam may be helpful in ameliorating the seizures in the early postoperative period .This pilot study is being done to compare phenytoin with levetiracetam for prophylaxis of seizures in TBI patients.
|