Ignite Creation Date:
2024-05-06 @ 2:00 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04189471
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2019-07-30
Brief Title:
Recovery After Cerebral Hemorrhage
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Recovery After Cerebral Hemorrhage--Improving Outcomes for Patients With Life-Threatening Neurologic Illness
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REACH
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 patients 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 Marylands 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
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 patients 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 Marylands 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
Detailed Description:
The objective of the proposed minimal-risk non-interventional retrospective January 2012 onwards as well as prospective cross-sectional observational study ie NCCU Research Repository is to better understand the common pathophysiological pathways of life-threatening neurological illnesses examine how systemic complications eg fever hyperglycemia undernutrition and infections and our standard-of care management of them may exacerbate brain injury and determine the impact of injury and intervention on functionally-relevant outcomes
A systematically collected cohort may have an especially important role in the NCCU where RCTs are difficult to implement or may lack generalizability and wherein there are pitfalls in research derived solely from administrative databases This relational database will capture all patients admitted to University of Marylands dedicated 22-bed adult NCCU The investigators will not initially collect all potentially relevant fields unique to specific diagnoses However future disease-specific studies will allow the addition of data fields in this flexible database environment This approach will include the tiered acquisition of patient characteristics age sex clinical characteristics standard-of-care medical treatments and surgical interventions physiological data such as vital signs cerebral blood flow intracranial pressure cerebral oximetry etc laboratory data and diagnostic studies--particularly neurophysiology neuropathology and neuroimaging Some data elements are inherently less reliable when abstracted from the electronic medical record eg a more detailed social history establishing premorbid functional status and independent confirmation of past medical history and will require an informed consent process to allow the research team to approach subjects or their surrogates
Similar databases exist at other centers for neurocritical care and have been central to the identification of characteristics both predictive and associative of patient outcomes Done properly this repository can facilitate many NCCU priorities including hypothesis generating determining feasibility of single-site trials or involvement in multi-center trials multimodal monitoring biomarker research quality improvement and resident education
All data will be collected from the patient medical record patient bedside monitors radiology PACS and laboratory systems The collection of data will not affect nor delay patient treatment at any instance
Potential subjects will include patients admitted to University of Marylands 22-bed NCCU for treatment of a life-threatening neurological illness All patients 18 years of age and older will be eligible for participation in the study
At the time study personnel approach the patient or the patients surrogate to discuss the study they will be provided with three options a Full Consent b Partial Refusal or c Complete Refusal
Subjects medical treatment will conform to existing clinical management protocols including routine ICU care Standard ICU protocols call for assessments of mental status several times a day The investigators would like to prospectively record the results of these exams in a rigorous standardized manner The investigators will attempt to correlate these assessments with clinical events and outcome In addition to standard clinical treatment details of each subjects hospitalization demographic profile past medical history family history will be obtained by questionnaire and chart review At discharge or 2 weeks after admission a brief examination and mental status test will be performed The subject and a family member or caregiver may also be asked to return for follow up evaluations 3 and 12 months after initial brain or spinal cord injury in order to evaluate their longterm neurological status disability emotional status cognitive functioning and overall quality of life These interviews may be conducted in person and will take approximately one hour each For those patients unable to return in person a shorter telephone interview will be conducted Outcome measures may include the Glasgow Outcome Scale GOS the extended Glasgow Outcome Scale eGOS Modified Rankin Scale Lawton Activities of Daily Living Index Barthel Index Sickness Impact Profile SIP NIH Stroke Scale psychosocial assessments memory and cognitive neuropsychometric tests eg the Montreal Cognitive Assessment-MoCA
Variables recorded during hospitalization will be examined for statistical correlation with neuropsychometric test results Candidate pathophysiologic variables with independent predictive value for cognitive dysfunction eg including severity of illness upon admission hydrocephalus ischemia from vasospasm and laboratory test results will be identified using Pearson correlation and forward stepwise logistic regression Relationships between acute pathology eg lesions on neuroimaging or malignant electrical patterns on electroencephalography and dysfunction within various cognitive domains memory attention visuospatial ability language will be examined using contingency tables Pearson correlation linear regression and the Wilcoxon signed rank test If necessary multivariate models will be used to confirm that significant independent relationships exist
Blood samples will be analyzed to identify the factors causing secondary brain injury eg the narrowing of the blood vessels vasospasm after initial hemorrhage
For patients requiring an External Ventricular Drain EVD as part of their medical treatment the cerebrospinal fluid CSF is drained into a collection bag the amount of drainage recorded and the CSF discarded The investigators may collect a 1 cc sample of the CSF daily prior to discard until it is medically warranted to remove the EVD or 14 days whichever comes first NO EVD will be placed for the purposes of clinical research
A systematically collected cohort may have an especially important role in the NCCU where RCTs are difficult to implement or may lack generalizability and wherein there are pitfalls in research derived solely from administrative databases This relational database will capture all patients admitted to University of Marylands dedicated 22-bed adult NCCU The investigators will not initially collect all potentially relevant fields unique to specific diagnoses However future disease-specific studies will allow the addition of data fields in this flexible database environment This approach will include the tiered acquisition of patient characteristics age sex clinical characteristics standard-of-care medical treatments and surgical interventions physiological data such as vital signs cerebral blood flow intracranial pressure cerebral oximetry etc laboratory data and diagnostic studies--particularly neurophysiology neuropathology and neuroimaging Some data elements are inherently less reliable when abstracted from the electronic medical record eg a more detailed social history establishing premorbid functional status and independent confirmation of past medical history and will require an informed consent process to allow the research team to approach subjects or their surrogates
Similar databases exist at other centers for neurocritical care and have been central to the identification of characteristics both predictive and associative of patient outcomes Done properly this repository can facilitate many NCCU priorities including hypothesis generating determining feasibility of single-site trials or involvement in multi-center trials multimodal monitoring biomarker research quality improvement and resident education
All data will be collected from the patient medical record patient bedside monitors radiology PACS and laboratory systems The collection of data will not affect nor delay patient treatment at any instance
Potential subjects will include patients admitted to University of Marylands 22-bed NCCU for treatment of a life-threatening neurological illness All patients 18 years of age and older will be eligible for participation in the study
At the time study personnel approach the patient or the patients surrogate to discuss the study they will be provided with three options a Full Consent b Partial Refusal or c Complete Refusal
Subjects medical treatment will conform to existing clinical management protocols including routine ICU care Standard ICU protocols call for assessments of mental status several times a day The investigators would like to prospectively record the results of these exams in a rigorous standardized manner The investigators will attempt to correlate these assessments with clinical events and outcome In addition to standard clinical treatment details of each subjects hospitalization demographic profile past medical history family history will be obtained by questionnaire and chart review At discharge or 2 weeks after admission a brief examination and mental status test will be performed The subject and a family member or caregiver may also be asked to return for follow up evaluations 3 and 12 months after initial brain or spinal cord injury in order to evaluate their longterm neurological status disability emotional status cognitive functioning and overall quality of life These interviews may be conducted in person and will take approximately one hour each For those patients unable to return in person a shorter telephone interview will be conducted Outcome measures may include the Glasgow Outcome Scale GOS the extended Glasgow Outcome Scale eGOS Modified Rankin Scale Lawton Activities of Daily Living Index Barthel Index Sickness Impact Profile SIP NIH Stroke Scale psychosocial assessments memory and cognitive neuropsychometric tests eg the Montreal Cognitive Assessment-MoCA
Variables recorded during hospitalization will be examined for statistical correlation with neuropsychometric test results Candidate pathophysiologic variables with independent predictive value for cognitive dysfunction eg including severity of illness upon admission hydrocephalus ischemia from vasospasm and laboratory test results will be identified using Pearson correlation and forward stepwise logistic regression Relationships between acute pathology eg lesions on neuroimaging or malignant electrical patterns on electroencephalography and dysfunction within various cognitive domains memory attention visuospatial ability language will be examined using contingency tables Pearson correlation linear regression and the Wilcoxon signed rank test If necessary multivariate models will be used to confirm that significant independent relationships exist
Blood samples will be analyzed to identify the factors causing secondary brain injury eg the narrowing of the blood vessels vasospasm after initial hemorrhage
For patients requiring an External Ventricular Drain EVD as part of their medical treatment the cerebrospinal fluid CSF is drained into a collection bag the amount of drainage recorded and the CSF discarded The investigators may collect a 1 cc sample of the CSF daily prior to discard until it is medically warranted to remove the EVD or 14 days whichever comes first NO EVD will be placed for the purposes of clinical research
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None