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Completed

NCT Number: NCT03033966

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.

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Key information

Conditions

Cerebral Venous Thrombosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Intracranial Embolism and Thrombosis Intracranial Thrombosis Nervous System Diseases Thromboembolism Vascular Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NIMHANS

Bengaluru, Karnataka, 560029, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIRS based Cerebral Oximetry

Device

Cerebral Oximetric measurement before and after decompressive craniectomy

Other names: Equanox, Nonin Medical, Inc. Plymouth, Minnesota, USA

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dhritiman Chakrabarti

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 27, 2017
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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