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NCT07614906RecruitingAccepts Healthy Volunteers

Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage

Massachusetts General Hospital

Start Date

3/3/2024

Completion Date

6/1/2027

Summary

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).

Detailed Description

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: * patients with SAH and vasospasm * patients with SAH and no vasospasm * control group

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adult * patient with SAH and with an external ventricular drainage (EVD) placed within 24 hours after the onset of the hemorrhage Exclusion Criteria: * pregnancy * pre-existing neurological comorbidities * coagulation disorders * anemia * absence of a good cranial window to perform Transcranial Doppler (TDC) * presence of \>50% stenosis of carotid arteries confirmed by doppler ultrasound * Technical problems on EVD that prevent CSF withdrawals 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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Conditions

Aneurysmal Subarachnoid HemorrhageCerebral Vasospasm

Locations

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00136

Italy