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Observational Study of Cerebral Venous Sinus Thrombosis in India

A Prospective, Longitudinal, Case Control, Observational Study of Cerebral Venous Sinus Thrombosis in Western Maharashtra, India. Risk Factors, Clinical Presentations and Complications. - CVST

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2013/01/003298
Enrollment
250
Registered
2013-01-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diagnosed case of cerebrovascular sinus thrombosis

Interventions

None listed

Sponsors

Pfizer Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males and females between 18 and 65 years of age. 2. Cerebral venous thrombosis confirmed by cerebral angiography (with intra-arterial contrast injection) or magnetic resonance venography or computed tomographic venography. 3. Patients or authorized representative must be able and willing to provide written informed consent. 4. Patients who are willing to or likely to comply with all study requirements. Inclusion for Control Arm Subjects 1. Age and gender matched healthy individuals from community or hospital patients with minor illnesses from general OPD without any neurological conditions or previous history of thrombosis or CVST who is willing to participate. 2. Males and females between 18 and 65 years of age. 3. Patients or authorized representative must be able and willing to provide written informed consent. 4. Patients who are willing to or likely to comply with all study requirements.

Exclusion criteria

Exclusion criteria: 1. Any known associated condition (such as cancer) with a poor short term (1 year) (terminal illness) prognosis independent of CVST. 2. Recent ( 3. Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the protocol visits). 4. Patients who are currently participating or had participated in other interventional study for last 30 days prior to their enrollment.

Design outcomes

Primary

MeasureTime frame
â?¢ The percentage of CVST patients with nutritional deficiencies as compared to normal population. â?¢ The percentage of CVST patients with abnormal thrombotic profile as compared to normal population.Timepoint: At baseline (1st visit i.e. study enrollment)

Secondary

MeasureTime frame
â?¢ The percentage of CVST patients with long term sequelae such as epilepsy, headaches, visual loss, pyramidal deficits and cognitive impairment. â?¢ The percentage of CVST patients with recurrence of CVST episode particularly after the first 12 months of the first episode, disability and death (as assessed by Modified Rankin Scale). Timepoint: 12 months

Countries

India

Contacts

Public ContactDr PG Divate

Jehangir Clinical Development Centre

pgdivate@gmail.com919370146613

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026