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HASH4-CSF: Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage

Sponsor
MaineHealth (Other)
Overall Status
Recruiting
CT.gov ID
NCT03604276
Collaborator
(none)
40
Enrollment
1
Location
84
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the relationship between the Neuroinflammatory response and headache pain after subarachnoid hemorrhage.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage (HASH4-CSF) - An Observational Trial
    Actual Study Start Date :
    Dec 1, 2017
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Characterization of the neuroinflammatory response in the CSF and blood of patients with non-traumatic SAH. [10 days]

    2. Determination of correlation between the neuroinflammatory response and severity/presence of headache pain. [10 days]

    3. Determination of correlation between the neuroinflammatory response and development of chronic headache. [1 year]

    Secondary Outcome Measures

    1. Comparison of the neuroinflammatory response in the CSF and blood in patients treated with dexamethasone versus other analgesics post SAH. [10 days]

    2. Comparison of dexamethasone versus other analgesics in their ability to improve measures of quality of life. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Non-traumatic subarachnoid hemorrhage

    • Age > 18 years

    • Treated with external ventricular drainage

    Exclusion Criteria:

    • Pregnancy or lactation

    • Age < 18 years

    • Traumatic SAH

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maine Medical Center Portland Maine United States 04102

    Sponsors and Collaborators

    • MaineHealth

    Investigators

    • Principal Investigator: Elizabeth K Glisic, PharmD, MaineHealth

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elizabeth Glisic, Clinical Pharmacist, MaineHealth
    ClinicalTrials.gov Identifier:
    NCT03604276
    Other Study ID Numbers:
    • 1100316-599
    First Posted:
    Jul 27, 2018
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Elizabeth Glisic, Clinical Pharmacist, MaineHealth
    Headache
    Subarachnoid hemorrhage
    Neuroinflammation
    Additional relevant MeSH terms:
    Subarachnoid Hemorrhage
    Hemorrhage
    Headache

    Study Results

    No Results Posted as of Sep 16, 2021