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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Venous Thrombosis
• Intervention / Treatment: Device: NIRS based Cerebral Oximetry

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore City, Karnataka, India, 560029
      • NIMHANS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Cerebral venous thrombosis for Decompressive craniectomy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contralateral Regional Cerebral Oxygen Saturation	Measurement of regional cerebral oxygen saturation over contralateral 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)
Systolic Blood Pressure	Measurement of systolic blood pressure before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.	From Recruitment till 48 hours postoperative (end of study)
Glasgow coma scale score	Measurement of Glasgow coma scale score before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.	From Recruitment till 48 hours postoperative (end of study)
Arterial blood gas measurement	Arterial blood gas measurement before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.	From Recruitment till 48 hours postoperative (end of study)
Haemoglobin	Haemoglobin measurement before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.	From Recruitment till 48 hours postoperative (end of study)

Collaborators and Investigators

• Sponsor: Dhritiman Chakrabarti

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2016
• Primary Completion (ACTUAL): June 30, 2016
• Study Completion (ACTUAL): June 30, 2016

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (ESTIMATE): January 27, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Decompressive Craniectomy; Cerebral Venous Thrombosis; Cerebral Oximetry
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: Item No.6.04, Neurosciences

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: May be shared on individual requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes