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| Name | Class |
|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
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The goal of this observational study is to understand if angiographic cerebral vasospasm (CV) can be predicted by levels of nitric oxide (NO) consumption in patients with aneurysmal subarachnoid hemorrhage (SAH). To reach this goal, the investigators will compare NO consumption levels in SAH and non-SAH patients. NO consumption levels will be analyzed from samples of participants' cerebral spinal fluid (CSF).
After enrollment, the investigators will collect patients' demographics and most relevant clinical characteristics of the patients.
For patients with SAH, the investigators will collect an-1 ml aliquot of CSF from the drainage circuit daily, (using a sterile procedure that involves a valve of the closed system circuit located distally to the patient, before the collection container), for a period of 15 days following SAH. The samples will be stored at -80 degrees.
The investigators will perform daily Transcranial Doppler (TCD) monitoring to assess whether the patients have cerebral vasospasm. In case of suspected vasospasm, and in all comatose patients after 4 days from the bleeding, a CT angiography will be performed to define the angiographic CV.
For the control group, discarded 1 ml-aliquot of CSF will be collected at the time of needle insertion for spinal anesthesia.
At the end of the protocol, the study population will be divided in 3 groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aneurysmal subarachnoid hemorrhage | Patients admitted to the Intensive Care Unit following spontaneous aneurysmal subarachnoid hemorrhage | ||
| Control | Patients without neurological comorbidities undergoing spinal anesthesia in the operating room |
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| Measure | Description | Time Frame |
|---|---|---|
| Nitric oxide consumption | Measurement taken from cerebrospinal fluid using nitric oxide consumption analyzer | Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia |
| Occurrence of cerebral vasospasm in patients with subarachnoid hemorrhage | Transcranial Doppler monitoring will provide peak systolic velocities (PSVs) at the middle (MCA), anterior (ACA), and posterior (PCA) cerebral arteries. Suspected vasospasm will be defined as a mean flow velocity >120 cm/s and a Lindegaard ratio (LR) ≥3. The LR will be obtained by dividing the mean flow velocities of the MCA by those of ipsilateral extracranial internal carotid artery. In case of suspected vasospasm, and in all comatose patients after 4 days from the bleeding, a CT angiography will be performed to define the angiographic CV. | Daily for 15 days following aneurysmal subarachnoid hemorrhage |
| Measure | Description | Time Frame |
|---|---|---|
| Nitric oxide metabolite levels | Measurement taken from cerebrospinal fluid | Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia |
| Free hemoglobin |
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Inclusion Criteria:
Exclusion Criteria:
For the control group, we will invite to participate patients without neurological comorbidities undergoing spinal anesthesia in the operating room or with a spinal drain for major vascular surgery.
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The cohort of patients with SAH will be selected from patients in the Intensive Care Unit at Gemelli Hospital in Rome, Italy, within 24 hours after the onset of the hemorrhage and with an external ventricular drain. The control group will be patients at Massachusetts General Hospital who are undergoing spinal anesthesia in the operating room, or those with a spinal drain for major vascular surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Berra, MD | Contact | 617-726-3030 | lberra@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Berra, MD | Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D020301 | Vasospasm, Intracranial |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Cerebrospinal fluid
Measurement taken from cerebrospinal fluid
| Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia |
| Fondazione Policlinico Universitario Agostino Gemelli | Recruiting | Rome | 00136 | Italy |
|
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |