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

NCT03033966 | Completed FDA Device

• 1 other identifier: Item No.6.04, Neurosciences
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Venous Thrombosis

Keywords

Cerebral Oximetry; Cerebral Venous Thrombosis; Decompressive Craniectomy

Outcome Measures

Primary Outcomes (1)

• Ipsilateral Regional Cerebral Oxygen Saturation

  Measurement of regional cerebral oxygen saturation over ipsilateral frontal lobe before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.

  From Recruitment till 48 hours postoperative (end of study)

Secondary Outcomes (5)

• Contralateral Regional Cerebral Oxygen Saturation

  From Recruitment till 48 hours postoperative (end of study)

• Systolic Blood Pressure

  From Recruitment till 48 hours postoperative (end of study)

• Glasgow coma scale score

  From Recruitment till 48 hours postoperative (end of study)

• Arterial blood gas measurement

  From Recruitment till 48 hours postoperative (end of study)

• Haemoglobin

  From Recruitment till 48 hours postoperative (end of study)

Interventions

NIRS based Cerebral Oximetry DEVICE

Cerebral Oximetric measurement before and after decompressive craniectomy

Also known as: Equanox, Nonin Medical, Inc. Plymouth, Minnesota, USA

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Cerebral venous thrombosis for Decompressive craniectomy

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dhritiman Chakrabarti: lead

Study Sites (1)

NIMHANS

Bengaluru, Karnataka, 560029, India

Location

MeSH Terms

Conditions

Intracranial Thrombosis

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: February 10, 2016
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: January 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)