Subarachnoid Hemorrhage, AneurysmalHASH4-CSFNCT03604276
Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage, Aneurysmal and Headache, run by MaineHealth at 1 site in United States.
Trial summary
The purpose of this study is to determine the relationship between the Neuroinflammatory response and headache pain after subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal, Headache, Subarachnoid Hemorrhage
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 1 Jan 2026
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Eligible patients are patients with a non-traumatic subarachnoid hemorrhage who are treated with an external ventricular drain for symptomatic hydrocephalus.
Who may be able to join
- Non-traumatic subarachnoid hemorrhage
- Age > 18 years
- Treated with external ventricular drainage
Who cannot join
- Pregnancy or lactation
- Age < 18 years
- Traumatic SAH
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage (HASH4-CSF) - An Observational Trial
The purpose of this study is to determine the relationship between the Neuroinflammatory response and headache pain after subarachnoid hemorrhage.
Read the detailed description
Persistent headache is a significant medical issue that affects 20% of patients who survive an aneurysmal subarachnoid hemorrhage (SAH). This headache may last years, severely affecting quality of life. Laboratory evidence suggests that the persistent headache may be a result of a maladaptive neuroinflammatory response to the hemorrhage injury that is more vigorous than necessary. The goal of this study is to measure key immunomodulators in the blood and the cerebrospinal fluid of these patients in order to determine the magnitude and dynamics of their neuroinflammatory response. In addition, the investigators will collect and analyze observational data about the success of medications to treat headache, with a specific focus on the anti-inflammatory agent dexamethasone, in managing acute headache pain and preventing the development of persistent headaches in patients after SAH.
- Keywords
- Headache, Subarachnoid hemorrhage, Neuroinflammation
- Medical subject headings
- Subarachnoid Hemorrhage, Headache, Neuroinflammatory Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the neuroinflammatory response in the CSF and blood of patients with non-traumatic SAH.
Measured: 10 days
Determination of correlation between the neuroinflammatory response and severity/presence of headache pain.
Measured: 10 days
Determination of correlation between the neuroinflammatory response and development of chronic headache.
Measured: 1 year
Secondary outcomes (2)
Comparison of the neuroinflammatory response in the CSF and blood in patients treated with dexamethasone versus other analgesics post SAH.
Measured: 10 days
Comparison of dexamethasone versus other analgesics in their ability to improve measures of quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Dec 2017
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Glisic, MaineHealth
- Investigators
- Elizabeth K Glisic, PharmD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604276
- Sponsor's protocol ID
- 1100316-599
- Acronym
- HASH4-CSF
- Status last verified
- Jan 2024
- First submitted
- 19 Jul 2018
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage (HASH4-CSF) - An Observational Trial
- ClinicalTrials.gov ID
- NCT03604276
- Acronym / sponsor ID
- HASH4-CSF / 1100316-599
- Keywords
- Headache, Subarachnoid hemorrhage, Neuroinflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 27 Jul 2018 (actual)
- 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.
The purpose of this study is to determine the relationship between the Neuroinflammatory response and headache pain after subarachnoid hemorrhage.
Detailed description
Persistent headache is a significant medical issue that affects 20% of patients who survive an aneurysmal subarachnoid hemorrhage (SAH). This headache may last years, severely affecting quality of life. Laboratory evidence suggests that the persistent headache may be a result of a maladaptive neuroinflammatory response to the hemorrhage injury that is more vigorous than necessary. The goal of this study is to measure key immunomodulators in the blood and the cerebrospinal fluid of these patients in order to determine the magnitude and dynamics of their neuroinflammatory response. In addition, the investigators will collect and analyze observational data about the success of medications to treat headache, with a specific focus on the anti-inflammatory agent dexamethasone, in managing acute headache pain and preventing the development of persistent headaches in patients after SAH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible patients are patients with a non-traumatic subarachnoid hemorrhage who are treated with an external ventricular drain for symptomatic hydrocephalus.
Key inclusion criteria (3 listed)
- Non-traumatic subarachnoid hemorrhage
- Age > 18 years
- Treated with external ventricular drainage
Key exclusion criteria (3 listed)
- Pregnancy or lactation
- Age < 18 years
- Traumatic SAH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of the neuroinflammatory response in the CSF and blood of patients with non-traumatic SAH.
Time frame: 10 days
Determination of correlation between the neuroinflammatory response and severity/presence of headache pain.
Time frame: 10 days
Determination of correlation between the neuroinflammatory response and development of chronic headache.
Time frame: 1 year
2 secondary outcomes
Comparison of the neuroinflammatory response in the CSF and blood in patients treated with dexamethasone versus other analgesics post SAH.
Time frame: 10 days
Comparison of dexamethasone versus other analgesics in their ability to improve measures of quality of life.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Elizabeth K Glisic, PharmD principal investigator
MaineHealth
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 and Headache, run by MaineHealth at 1 site in United States.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jan 2024. 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 United States. 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?
Results are not available in the source record.
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?
Characterization of the neuroinflammatory response in the CSF and blood of patients with non-traumatic SAH. (time frame: 10 days). The study lists 3 primary outcomes in all. 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 9 Jan 2024.