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

January 8, 2024 updated by: Elizabeth Glisic, MaineHealth

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ashley Eldridge, BSN, RN
  • Phone Number: 207-662-3231
  • Email: eldria@mmc.org

Study Contact Backup

  • Name: Christine Lord, BSN, RN-BC
  • Phone Number: 207-662-5206
  • Email: lordc@mmc.org

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Eligible patients are patients with a non-traumatic subarachnoid hemorrhage who are treated with an external ventricular drain for symptomatic hydrocephalus.

Description

Inclusion Criteria:

  • Non-traumatic subarachnoid hemorrhage
  • Age > 18 years
  • Treated with external ventricular drainage

Exclusion Criteria:

  • Pregnancy or lactation
  • Age < 18 years
  • Traumatic SAH

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterization of the neuroinflammatory response in the CSF and blood of patients with non-traumatic SAH.
Time Frame: 10 days
10 days
Determination of correlation between the neuroinflammatory response and severity/presence of headache pain.
Time Frame: 10 days
10 days
Determination of correlation between the neuroinflammatory response and development of chronic headache.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of the neuroinflammatory response in the CSF and blood in patients treated with dexamethasone versus other analgesics post SAH.
Time Frame: 10 days
10 days
Comparison of dexamethasone versus other analgesics in their ability to improve measures of quality of life.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MaineHealth

Investigators

  • Principal Investigator: Elizabeth K Glisic, PharmD, MaineHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1100316-599

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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