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

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ClinicalTrials.gov Identifier: NCT03033966
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India

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.

Condition or disease Intervention/treatment
Cerebral Venous Thrombosis Device: NIRS based Cerebral Oximetry

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis
Actual Study Start Date : February 10, 2016
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: NIRS based Cerebral Oximetry
    Cerebral Oximetric measurement before and after decompressive craniectomy
    Other Name: Equanox, Nonin Medical, Inc. Plymouth, Minnesota, USA


Primary Outcome Measures :
  1. Ipsilateral Regional Cerebral Oxygen Saturation [ Time Frame: 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 :
  1. Contralateral Regional Cerebral Oxygen Saturation [ Time Frame: 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.

  2. Systolic Blood Pressure [ Time Frame: 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.

  3. Glasgow coma scale score [ Time Frame: 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.

  4. Arterial blood gas measurement [ Time Frame: 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.

  5. Haemoglobin [ Time Frame: 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.



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Cerebral venous thrombosis for Decompressive craniectomy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033966


Locations
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India
NIMHANS
Bangalore City, Karnataka, India, 560029
Sponsors and Collaborators
Dhritiman Chakrabarti
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Responsible Party: Dhritiman Chakrabarti, Assistant Professor, National Institute of Mental Health and Neuro Sciences, India
ClinicalTrials.gov Identifier: NCT03033966    
Other Study ID Numbers: Item No.6.04, Neurosciences
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: May be shared on individual requests

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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
Keywords provided by Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India:
Cerebral Oximetry
Cerebral Venous Thrombosis
Decompressive Craniectomy
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases