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Recovery After Cerebral Hemorrhage (REACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04189471
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Gunjan Parikh, University of Maryland, Baltimore

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.


Condition or disease
Intra Cerebral Hemorrhage Subarachnoid Hemorrhage Intraventricular Hemorrhage Nontraumatic Haemorrhage

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Recovery After Cerebral Hemorrhage--Improving Outcomes for Patients With Life-Threatening Neurologic Illness
Actual Study Start Date : September 8, 2014
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Number of participants who score great than 60 on the Barthel Index [ Time Frame: 3 month ]
    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.

  2. Number of participants who score great than 26 on the Montreal Cognitive Assessment (MoCA) [ Time Frame: 3 month ]
    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. Number of participants who score 1 or less on the Modified Rankin Scale [ Time Frame: 3 month ]
    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.

  4. Number of participants who have experienced adverse events [ Time Frame: 3 month ]
    Medical history from hospital discharge to three months will help researchers learn of any adverse events or other medical complications.

  5. Number of participants who score great than 75 on the EuroQOL [ Time Frame: 3 month ]
    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).


Biospecimen Retention:   Samples With DNA
12 mL of blood to be collected for RNA, DNA, and plasma


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

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

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): NCT04189471


Contacts
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Contact: Gunjan Parikh 4103284515 gparikh@som.umaryland.edu
Contact: Lakshman Kalasapudi 4103282913 lkalasapudi@som.umaryland.edu

Locations
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United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Gunjan Parikh, M.D.    410-328-4515    gparikh@som.umaryland.edu   
Contact: Lakshman Kalasapudi, M.A.    4103282913    lkalasapudi@som.umaryland.edu   
Sponsors and Collaborators
University of Maryland, Baltimore

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Responsible Party: Gunjan Parikh, Assistant Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT04189471    
Other Study ID Numbers: HP-00056063
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019

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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 Gunjan Parikh, University of Maryland, Baltimore:
hemorrhage
intracerebral hemorrhage
SAH
Nontraumatic Haemorrhage
ICH
subarachnoid hemorrhage
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Brain Diseases
Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases