Subarachnoid Hemorrhage
Conditions
Keywords
Cerebrospinal Fluid, Ventriculostomy, Subarachnoid hemorrhage, vasospasm, Human Subjects
Brief summary
The purpose of this study is explore how cerebrospinal fluid (CSF) drainage impacts outcomes for patients diagnosed with subarachnoid hemorrhage (SAH). This is a non-randomized observational study of two physician-prescribed approaches to managing intracranial pressure monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have intracranial pressure (ICP) monitoring in situ. Because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.
Detailed description
There are no interventions specific to this observational study. The nurses and physicians who care for subjects in the study are already competent in the care and management of patients with subarachnoid hemorrhage (SAH) and intracranial pressure (ICP) monitoring as a requirement of their current employment at Duke University. Patients with confirmed diagnosis of subarachnoid hemorrhage requiring ICP and CSF management will be admitted to the 16 bed Neurocritical Care Unit (NCCU) at Duke Hospital. After admission procedures and a baseline neurologic assessment are complete, the charge nurse or NCCU fellow will notify an investigator of subjects meeting inclusion criteria. The investigator or research coordinator for this project will complete a review preparatory to research (RPR) to ensure no exclusion criteria are present and once subject appropriateness has been confirmed patients and their families will be introduced to the investigator for the purpose of obtaining informed consent. The subject's legally authorized representative (LAR) will be informed of the study's purpose, risks and benefits, and the rights of research subjects. Data will be collected that reflects the duration of the patient's hospitalization at Duke University through chart abstraction. The study period will be defined as admission to discharge. The attending physician has, and will continue to, determine the appropriateness of the duration of ICP monitoring, NCCU discharge criteria and hospital discharge criteria. Chart abstraction will be completed daily to obtain the ICP values and CSF volumes during that period of time for which the patient has a ventriculostomy.
Interventions
None listed
Sponsors
Duke University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of subarachnoid hemorrhage * Age 18 years or older * Ventriculostomy in situ
Exclusion criteria
* Prisoners * Glasgow coma score = 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Artery Vasospasm | 14 days | Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| External Ventricular Drain (EVD) Complications | 14 Days | External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient. |
| Cerebrospinal Fluid (CSF) Output Per Day | 14 Days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ventriculostomy Open Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag. | 24 |
| Ventriculostomy Monitored Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician. | 13 |
| Total | 37 |
Baseline characteristics
| Characteristic | Ventriculostomy Monitored | Ventriculostomy Open | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 20 Participants | 30 Participants |
| Age, Continuous | 53.13 years STANDARD_DEVIATION 11.13 | 55.92 years STANDARD_DEVIATION 13.35 | 54.11 years STANDARD_DEVIATION 11.85 |
| Region of Enrollment United States | 13 participants | 24 participants | 37 participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 25 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 13 |
| serious Total, serious adverse events | 0 / 24 | 0 / 13 |
Outcome results
Primary
Cerebral Artery Vasospasm
Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ventriculostomy Open | Cerebral Artery Vasospasm | 16 Participants |
| Ventriculostomy Monitored | Cerebral Artery Vasospasm | 7 Participants |
Secondary
Cerebrospinal Fluid (CSF) Output Per Day
Time frame: 14 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ventriculostomy Open | Cerebrospinal Fluid (CSF) Output Per Day | 134 Milliliter |
| Ventriculostomy Monitored | Cerebrospinal Fluid (CSF) Output Per Day | 135 Milliliter |
Secondary
External Ventricular Drain (EVD) Complications
External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.
Time frame: 14 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ventriculostomy Open | External Ventricular Drain (EVD) Complications | 14 Participants |
| Ventriculostomy Monitored | External Ventricular Drain (EVD) Complications | 4 Participants |