| CTRI Number |
CTRI/2024/10/075135 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
A model to predict outcomes after clot in veins of Brain |
|
Scientific Title of Study
|
Cerebral Venous Sinus Thrombosis (CVST) Score: A Prognostic Score for Clinical Outcomes in Cerebral Venous Sinus Thrombosis. |
| 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 Aakriti Vij |
| Designation |
Senior Resident Neurology |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Neurology, Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural hospital, Sawngi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766968318 |
| Fax |
|
| Email |
vijaakriti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar Patil |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Neurology, Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural hospital, Sawngi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9021810293 |
| Fax |
|
| Email |
tushar.neuro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aakriti Vij |
| Designation |
Senior Resident Neurology |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Neurology, Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural hospital, Sawngi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766968318 |
| Fax |
|
| Email |
vijaakriti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital
Datta Meghe University of Higher Education and Research
Sawangi, Wardha, Maharashtra- 442001 |
|
|
Primary Sponsor
|
| Name |
Aakriti Vij |
| Address |
Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Hospital, Datta Meghe university of Higher Education and Research, Sawangi, Wardha, Maharashtra-442001 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Aakriti Vij |
Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital |
Department of Neurology,
Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital, Sawanghi Meghe, Wardha
Wardha
MAHARASHTRA |
9766968318
vijaakriti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I676||Nonpyogenic thrombosis of intracranial venous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Clinical features suggestive of Cerebral Venous Sinus Thrombosis
2)MRV of Brain consistent with thrombosis of any one or more than one of the following cerebral venous sinuses: Superior sagittal sinus, Straight sinus, Transverse sinus, Sigmoid sinus, Internal jugular vein.
3)If MRI is contraindicated, then CT Venography or Digital Subtraction Venography consistent with thrombosis of any one or more than one of the following cerebral venous sinuses: Superior sagittal sinus, Straight sinus, Transverse sinus, Sigmoid sinus, Internal jugular vein.
|
|
| ExclusionCriteria |
| Details |
1)Age less than 18 years
2)Arterial Ischemic Stroke
3)Aneurysmal Subarachnoid Hemorrhage
4)Traumatic Intracranial Hemorrhage
5)Hypertensive Intracranial Hemorrhage
6)Cerebral Amyloid Angiopathy
7)Presence of Contraindications for anticoagulation such as active bleeding hemophilia or other hemorrhagic tendencies severe liver disease with elevated baseline prothrombin time severe thrombocytopenia (platelet count less than 20000).
8)Cortical Venous Thrombosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional Status of the patient determined by the use of Modified Rankin Scale |
at time of discharge and at 1 month after discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Resolution of hemorrhage & perilesional edema
2.Need of decompressive craniotomy
3.Length of ICU stay
4.Need of ventilatory support
5.Need of hospital stay |
at time of discharge & 1 month follow up after discharge |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vijaakriti@gmail.com].
- For how long will this data be available start date provided 30-11-2026 and end date provided 20-11-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Cerebral Venous Sinus Thrombosis(CVST) is a disease with variable
outcomes. There are multiple factors including clinical and radiological
parameters which impact the outcome of patients. There are multiple scoring
systems for prognostication in Neurological disorders such as Ischemic Stroke,
Intracerebral Haemorrhage and Subarachnoid Haemorrhage. However, there is no clinico-radiological
scoring system for patients with CVST. The rationale for this study is to
develop a novel comprehensive scoring system that will help to determine
prognosis of patients with CVST. Such information will be immensely helpful for
clinicians and patient families. |