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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03033966

Enrollment

Registered

2017-01-27

Start date

2016-02-10

Completion date

2016-06-30

Last updated

2017-01-27

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

Conditions

Cerebral Venous Thrombosis

Keywords

Cerebral Oximetry, Cerebral Venous Thrombosis, Decompressive Craniectomy

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.

Interventions

DEVICENIRS based Cerebral Oximetry

Cerebral Oximetric measurement before and after decompressive craniectomy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026