Cerebral Venous ThrombosisNCT03033966
Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis
An observational study of Cerebral Venous Thrombosis, run by Dhritiman Chakrabarti at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Cerebral Venous Thrombosis
- What is being tested?
- NIRS based Cerebral Oximetry
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteIndia
- Study dates
- 10 Feb 2016to 30 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Cerebral venous thrombosis for Decompressive craniectomy
Who may be able to join
- -Patients diagnosed with cerebral venous thrombosis, undergoing decompressive craniectomy.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cerebral Venous Thrombosis
- Being tested
- NIRS based Cerebral Oximetry
- Keywords
- Cerebral Oximetry, Cerebral Venous Thrombosis, Decompressive Craniectomy
- Medical subject headings
- Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS based Cerebral OximetryDevice
Also called Equanox, Nonin Medical, Inc. Plymouth, Minnesota, USA
Cerebral Oximetric measurement before and after decompressive craniectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Recruitment till 48 hours postoperative (end of study)
Secondary outcomes (5)
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.
Measured: From Recruitment till 48 hours postoperative (end of study)
Systolic Blood Pressure
Measurement of systolic blood pressure before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.
Measured: From Recruitment till 48 hours postoperative (end of study)
Glasgow coma scale score
Measurement of Glasgow coma scale score before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.
Measured: From Recruitment till 48 hours postoperative (end of study)
Arterial blood gas measurement
Arterial blood gas measurement before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.
Measured: From Recruitment till 48 hours postoperative (end of study)
Haemoglobin
Haemoglobin measurement before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.
Measured: From Recruitment till 48 hours postoperative (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start10 Feb 2016
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Venous ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhritiman Chakrabarti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033966
- Sponsor's protocol ID
- Item No.6.04, Neurosciences
- Status last verified
- Jan 2017
- First submitted
- 25 Jan 2017
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: May be shared on individual requests
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis
- ClinicalTrials.gov ID
- NCT03033966
- Acronym / sponsor ID
- Item No.6.04, Neurosciences
- Conditions
- Cerebral Venous Thrombosis
- Keywords
- Cerebral Oximetry, Cerebral Venous Thrombosis, Decompressive Craniectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Dhritiman ChakrabartiUniversity, hospital or other
- Study start
- 10 Feb 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Cerebral venous thrombosis for Decompressive craniectomy
Key inclusion criteria (1 listed)
- -Patients diagnosed with cerebral venous thrombosis, undergoing decompressive craniectomy.
Key exclusion criteria (8 listed)
- Patients on inotropic support
- Systolic blood pressure < 90 mmHg
- Haemoglobin oxygen saturation <95%
- Refusal of consent
- Age <16 and > 65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS based Cerebral OximetryAlso: Equanox, Nonin Medical, Inc. Plymouth, Minnesota, USACerebral Oximetric measurement before and after decompressive craniectomy | Device | – |
Primary outcome
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.
5 secondary outcomes
Contralateral Regional Cerebral Oxygen Saturation
Time frame: From Recruitment till 48 hours postoperative (end of study)
Systolic Blood Pressure
Time frame: From Recruitment till 48 hours postoperative (end of study)
Glasgow coma scale score
Time frame: From Recruitment till 48 hours postoperative (end of study)
Arterial blood gas measurement
Time frame: From Recruitment till 48 hours postoperative (end of study)
Haemoglobin
Time frame: From Recruitment till 48 hours postoperative (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Individual participant dataSharing planned: No. May be shared on individual requests
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Venous Thrombosis, run by Dhritiman Chakrabarti at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral Regional Cerebral Oxygen Saturation (time frame: From Recruitment till 48 hours postoperative (end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.