Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis

NCT ID: NCT03033966

Last Updated: 2017-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-10

Study Completion Date

2016-06-30

Brief Summary

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Cerebral hypoperfusion and hypoxia are the major determinants of neurological outcomes following acute brain injury as proved in Traumatic Brain Injury/Sub Arachnoid Haemhorrhage literature. How the brain injury affects cerebral oxygenation in patients with CVT is not currently known. Some of the factors that can affect cerebral oxygenation in patients with CVT are Hemoglobin, PO2, PCO2, Cerebral Perfusion Pressure (or MAP) and change in Intracranial Pressure after Decompressive Craniectomy. This study is designed to study how these factors affect cerebral oxygenation and impact of Decompressive Craniectomy on the cerebral oxygenation.

Detailed Description

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Conditions

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Cerebral Venous Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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NIRS based Cerebral Oximetry

Cerebral Oximetric measurement before and after decompressive craniectomy

Intervention Type DEVICE

Other Intervention Names

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Equanox, Nonin Medical, Inc. Plymouth, Minnesota, USA

Eligibility Criteria

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Inclusion Criteria

-Patients diagnosed with cerebral venous thrombosis, undergoing decompressive craniectomy.

Exclusion Criteria

* Patients on inotropic support
* Systolic blood pressure \< 90 mmHg
* Haemoglobin oxygen saturation \<95%
* Refusal of consent
* Age \<16 and \> 65 years
* Known history of diabetes or hypertension
* Pregnancy
* Any contraindication for application of cerebral oximetry sensors
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dhritiman Chakrabarti

OTHER

Sponsor Role lead

Responsible Party

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Dhritiman Chakrabarti

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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NIMHANS

Bengaluru, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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Item No.6.04, Neurosciences

Identifier Type: -

Identifier Source: org_study_id

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