Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03604276

Acronym

HASH4-CSF

Enrollment

Registered

2018-07-27

Start date

2017-12-01

Completion date

2026-01-01

Last updated

2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal

Keywords

Headache, Subarachnoid hemorrhage, Neuroinflammation

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* Pregnancy or lactation * Age \< 18 years * Traumatic SAH

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results