Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH)
NCT00692744
Aneurysm, Aneurysmal Subarachnoid Hemorrhage
Rouen, France
View Trial DetailsNCT Number: NCT07614906
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Time frame: Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
Measurement taken from cerebrospinal fluid using nitric oxide consumption analyzer
Time frame: Daily for 15 days following aneurysmal 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.
Time frame: Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
Measurement taken from cerebrospinal fluid
Time frame: Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
Measurement taken from cerebrospinal fluid
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage (SAH): a Prospective Observational Study
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