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

Cerebral Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033966
• Other study ID #: Item No.6.04, Neurosciences
• Status: Completed
• Phase: N/A
• First received: January 25, 2017
• Last updated: January 26, 2017
• Start date: February 10, 2016
• Est. completion date: June 30, 2016

Study information

• Verified date: January 2017
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• NIRS based Cerebral Oximetry
Cerebral Oximetric measurement before and after decompressive craniectomy

Locations

Country	Name	City	State
India	NIMHANS	Bangalore City	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Dhritiman Chakrabarti

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)