Subarachnoid Hemorrhage Clinical Trial
— REACHOfficial title:
Recovery After Cerebral Hemorrhage--Improving Outcomes for Patients With Life-Threatening Neurologic Illness
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | January 1, 2034 |
Est. primary completion date | January 1, 2034 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05131295 -
Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage.
|
Phase 3 | |
Recruiting |
NCT02962349 -
TRansfusion Strategies in Acute Brain INjured Patients
|
N/A | |
Completed |
NCT02872857 -
Subarachnoid Hemorrhage Recovery And Galantamine
|
Phase 1/Phase 2 | |
Completed |
NCT03164434 -
Influence of Drainage on EVD ICP-signal
|
||
Terminated |
NCT02216513 -
Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
|
Phase 0 | |
Completed |
NCT02389634 -
Identification of Novel Molecular Markers for Vasospasm
|
||
Completed |
NCT01077206 -
High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT00905931 -
Lycopene Following Aneurysmal Subarachnoid Haemorrhage
|
Phase 2 | |
Completed |
NCT01261091 -
Early Tracheostomy in Ventilated Stroke Patients
|
N/A | |
Completed |
NCT00962546 -
Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage
|
N/A | |
Completed |
NCT00507104 -
Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
|
||
Completed |
NCT00071565 -
Familial Intracranial Aneurysm Study II
|
N/A | |
Recruiting |
NCT05113381 -
The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of IVH
|
N/A | |
Completed |
NCT04052646 -
Prehospital Deaths From Spontaneous Subarachnoid Haemorrhages
|
||
Recruiting |
NCT04548596 -
NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
|
||
Recruiting |
NCT06033378 -
Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage.
|
N/A | |
Completed |
NCT04308577 -
Diet Induced Ketosis for Brain Injury - A Feasibility Study
|
N/A | |
Recruiting |
NCT06103201 -
Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury
|
Phase 1 |