Improving Outcomes for Patients With Life-Threatening Neurologic Illness

NCT04189471 | Recruiting

• 1 other identifier: HP-00056063
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Number of participants who score great than 60 on the Barthel Index

  The Barthel scale is an ordinal scale used to measure performance in activities of daily living. Scores range from 0 to 100. A higher score signifies better outcomes, more independent functionality.

  3 month

• Number of participants who score great than 26 on the Montreal Cognitive Assessment (MoCA)

  The Montreal Cognitive Assessment was developed as a quick screening tool for neurological function. It assesses the domains of attention and concentration, executive function, memory, language, visuoconstructional skills, conceptual thinking, calculation, and orientation. The MoCA has been tested extensively for use in a variety of disorders affecting cognition such as HIV, Huntington's chorea, Multiple Sclerosis, Parkinson's disease, stroke, vascular dementia, and substance abuse in addition to the wellness of older adults. The MoCA has been tested in ages ranging from as young as 49 in two reports to old-old (85+) with a variety of education levels. The total possible score is 30 points with a score of 26 or more considered normal.

  3 month

• Number of participants who score 1 or less on the Modified Rankin Scale

  The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke. Scores range from 0 to 6. A lower score signifies better outcomes, more independent functionality.

  3 month

• Number of participants who have experienced adverse events

  Medical history from hospital discharge to three months will help researchers learn of any adverse events or other medical complications.

  3 month

• Number of participants who score great than 75 on the EuroQOL

  EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

  3 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in University of Maryland Medical Center's Neurocritical Care Unit with potentially life-threatening neurological illness aged 18 and older.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (1)

• Zimmerman W, Pergakis M, Ahmad G, Morris NA, Podell J, Chang WT, Motta M, Chen H, Jindal G, Bodanapally U, Marc Simard J, Badjatia N, Parikh GY. Iodine-Based Dual-Energy Computed Tomography After Mechanical Thrombectomy Predicts Secondary Neurologic Decline from Cerebral Edema After Severe Stroke. Neurocrit Care. 2025 Jun;42(3):804-816. doi: 10.1007/s12028-024-02137-5. Epub 2024 Oct 24.

  PMID: 39448427 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

12 mL of blood to be collected for RNA, DNA, and plasma

MeSH Terms

Conditions

Cerebral Hemorrhage; Subarachnoid Hemorrhage; Status Epilepticus; Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Seizures; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Gunjan Y Parikh, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gunjan Parikh

CONTACT

4103284515; gparikh@som.umaryland.edu

Mayurapriyan Somalinga

CONTACT

4103284515; msomalinga@som.umaryland.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: December 6, 2019
• Study Start: September 8, 2014
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2034
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

US (1)