Subarachnoid Hemorrhage, AneurysmalNCT02991157
Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
Trial summary
This prospective observational study will assess the regional cerebral oxygen saturation and cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine administration for the prevention/management of cerebral vasospasm. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Nimodipine
- How many people
- 25 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2016to Dec 2018
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: aneurysmal subarachnoid hemorrhage with cerebral vasospasm
Who may be able to join
- aneurysmal subarachnoid hemorrhage
- potential or actual cerebral vasospasm
Who cannot join
- non-aneurysmal subarachnoid hemorrhage
- outside the 4-21 day window after ictus
- peripheral deoxygenation
- contraindication for nimodipine administration
Trial locations and contacts
1 site in 1 country.
About this study
This prospective observational study will assess the regional cerebral oxygen saturation and cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine administration for the prevention/management of cerebral vasospasm.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- Nimodipine
- Keywords
- cerebral vasospasm, nimodipine
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimodipineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine
Measured: Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine
Secondary outcomes (2)
Change in the cardiac output measured using near NICOM technology after administration of nimodipine
unit of measurement will be L/min
Measured: Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine
Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine
Measured: Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionNov 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sriganesh Kamath, National Institute of Mental Health and Neuro Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991157
- Sponsor's protocol ID
- 12.02
- Status last verified
- Mar 2019
- First submitted
- 7 Dec 2016
- Last updated
- 26 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases
- ClinicalTrials.gov ID
- NCT02991157
- Acronym / sponsor ID
- 12.02
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- cerebral vasospasm, nimodipine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 13 Dec 2016 (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.
This prospective observational study will assess the regional cerebral oxygen saturation and cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine administration for the prevention/management of cerebral vasospasm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- aneurysmal subarachnoid hemorrhage with cerebral vasospasm
Key inclusion criteria (2 listed)
- aneurysmal subarachnoid hemorrhage
- potential or actual cerebral vasospasm
Key exclusion criteria (4 listed)
- non-aneurysmal subarachnoid hemorrhage
- outside the 4-21 day window after ictus
- peripheral deoxygenation
- contraindication for nimodipine administration
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 |
|---|---|---|
| Nimodipine | Drug | – |
Primary outcome
Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine
Time frame: Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine
2 secondary outcomes
Change in the cardiac output measured using near NICOM technology after administration of nimodipine
Time frame: Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine
Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine
Time frame: Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine
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 26 Mar 2019.
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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 Subarachnoid Hemorrhage, Aneurysmal, run by National Institute of Mental Health and Neuro Sciences, India 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 2 inclusion and 4 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 26 Mar 2019. 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?
Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine (time frame: Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine). 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 26 Mar 2019.