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

Completed

• Conditions: Cerebral Venous Thrombosis

• Registration Number: NCT03033966
• Lead Sponsor: Dhritiman Chakrabarti

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-10
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2017-01
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-26
• Last Update Submitted: 2017-01-26
• Study First Posted: 2017-01-27
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ipsilateral Regional Cerebral Oxygen Saturation	From Recruitment till 48 hours postoperative (end of study)	Measurement of regional cerebral oxygen saturation over ipsilateral frontal lobe before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NIMHANS; 🇮🇳 Bangalore City, Karnataka, India