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Trial record 71 of 194 for:    Hemorrhage AND SAH

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

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ClinicalTrials.gov Identifier: NCT03604276
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Elizabeth Glisic, Maine Medical Center

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
Subarachnoid Hemorrhage, Aneurysmal Headache 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.

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Study Type : Observational
Estimated 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 : December 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Characterization of the neuroinflammatory response in the CSF and blood of patients with non-traumatic SAH. [ Time Frame: 10 days ]
  2. Determination of correlation between the neuroinflammatory response and severity/presence of headache pain. [ Time Frame: 10 days ]
  3. Determination of correlation between the neuroinflammatory response and development of chronic headache. [ Time Frame: 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. [ Time Frame: 10 days ]
  2. Comparison of dexamethasone versus other analgesics in their ability to improve measures of quality of life. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604276


Contacts
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Contact: Ashley Eldridge, BSN, RN 207-662-3231 eldria@mmc.org
Contact: Christine Lord, BSN, RN-BC 207-662-5206 lordc@mmc.org

Locations
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United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Ashley Eldridge, BSN, RN    207-662-3231    eldria@mmc.org   
Sponsors and Collaborators
Maine Medical Center
Investigators
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Principal Investigator: Elizabeth K Glisic, PharmD Maine Medical Center

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Responsible Party: Elizabeth Glisic, Clinical Pharmacist, Maine Medical Center
ClinicalTrials.gov Identifier: NCT03604276     History of Changes
Other Study ID Numbers: 1100316-599
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elizabeth Glisic, Maine Medical Center:
Headache
Subarachnoid hemorrhage
Neuroinflammation

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Headache
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases