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NCT03604276 Clinical Trial

Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage

Headache Clinical Trial

— HASH4-CSF  

Official title:
Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage (HASH4-CSF) - An Observational Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03604276
Other study ID # 1100316-599
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date January 1, 2026

Study information
Verified date January 2024
Source MaineHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date January 1, 2026
Est. primary completion date January 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Maine Medical Center Portland Maine

Sponsors (1)
Lead Sponsor Collaborator
MaineHealth

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Characterization of the neuroinflammatory response in the CSF and blood of patients with non-traumatic SAH. 10 days
Primary Determination of correlation between the neuroinflammatory response and severity/presence of headache pain. 10 days
Primary Determination of correlation between the neuroinflammatory response and development of chronic headache. 1 year
Secondary Comparison of the neuroinflammatory response in the CSF and blood in patients treated with dexamethasone versus other analgesics post SAH. 10 days
Secondary Comparison of dexamethasone versus other analgesics in their ability to improve measures of quality of life. 1 year
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