Recruiting

Observational Study

Sponsor:

University of Maryland, Baltimore

Code:

NCT04189471

Conditions

Intracerebral Hemorrhage

Subarachnoid Hemorrhage

Intraventricular Hemorrhage

Nontraumatic Haemorrhage

Status Epilepticus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Background:

While the intensive care of patients with life-threatening brain illnesses has advanced tremendously, a large number of therapies are still without proper scientific support.

This can be partly explained by the fact that mechanisms of initial brain injury are still not well understood. Why additional neurological injury occurs during a patient's stay in the NeuroCritical Care Unit (NCCU) despite current best, evidence-based clinical practices, is also not well understood. However, over the past decade, better tools have become available to measure and monitor the impact of our clinical care on the rapidly changing physiology and chemistry of the injured brain. Some of these tools are CT, MRI, ultrasound, and catheter-based technology measuring blood flow and metabolism. These tools have enabled earlier detection of injury and complications and newer therapeutic strategies.

Purpose:

Examine disease pathways common to all brain injuries seen in the University of Maryland's 22-bed NCCU. Life-threatening neurological illnesses cared for in the NCCU include massive stroke, bleeding in and around the brain (subarachnoid hemorrhage, intracerebral hemorrhage, subdural hemorrhage, intraventricular hemorrhage), brain tumors, difficult to control seizures, neurologic infections, nerve and muscle diseases (such as myasthenia gravis or Guillain-Barre Syndrome), and spinal cord disorders among others. Many NCCU patients are comatose or paralyzed and may suffer injuries in other parts of the body as well.

This effort will require the creation of a robust clinical database for the capture of data including patient characteristics (age, sex), clinical characteristics, medical treatments, surgical interventions, physiological data (such as vital signs, cerebral blood flow, intracranial pressure, cerebral oximetry, etc), laboratory data, and standard-of-care diagnostic studies such as electroencephalography (EEG), ultrasound, CT, MRI, and angiograms. Similar databases exist at other major centers for neurocritical care and have been instrumental to the identification of characteristics both predictive of and associated with outcomes of patients long after their stay in the NCCU.

In addition, the samples collected will be included in the University of Maryland Medicine (UMM) Biorepository which is a shared resource to enable biomedical research by University of Maryland faculty.

Conditions

Intracerebral Hemorrhage

Subarachnoid Hemorrhage

Intraventricular Hemorrhage

Nontraumatic Haemorrhage

Status Epilepticus

Study ID

NCT04189471

Start date

Sep 8, 2014

Status verified date

Jun, 2026

Completion date

Jan 1, 2034

Anticipated

Primary completion date

Jan 1, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • clinical diagnosis of potentially life-threatening neurological illness
  • admitted to Neuro ICU within 14 days of initial injury

Exclusion Criteria:

  • known pre-existing neurological deficits related to a developmental disorder
  • prior severe stroke
  • prior severe dementia
  • prior severe head injury
  • prisoners

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of participants who score great than 60 on the Barthel Index [ Time Frame: 3 month ]
  • Number of participants who score great than 26 on the Montreal Cognitive Assessment (MoCA) [ Time Frame: 3 month ]
  • Number of participants who score 1 or less on the Modified Rankin Scale [ Time Frame: 3 month ]
  • Number of participants who have experienced adverse events [ Time Frame: 3 month ]
  • Number of participants who score great than 75 on the EuroQOL [ Time Frame: 3 month ]

Central Contacts and Locations

Central contacts

Locations

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • hemorrhage
  • intracerebral hemorrhage
  • SAH
  • Nontraumatic Haemorrhage
  • ICH
  • subarachnoid hemorrhage
  • status epilepticus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-02.