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Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage

Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage (SAH): a Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07614906
Enrollment
40
Registered
2026-05-29
Start date
2024-03-03
Completion date
2027-06-01
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm

Keywords

Nitric Oxide Consumption

Brief 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

Interventions

None listed

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Nitric oxide consumptionDaily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesiaMeasurement taken from cerebrospinal fluid using nitric oxide consumption analyzer
Occurrence of cerebral vasospasm in patients with subarachnoid hemorrhageDaily for 15 days following aneurysmal subarachnoid hemorrhageTranscranial 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.

Secondary

MeasureTime frameDescription
Nitric oxide metabolite levelsDaily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesiaMeasurement taken from cerebrospinal fluid
Free hemoglobinDaily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesiaMeasurement taken from cerebrospinal fluid

Countries

Italy, United States

Contacts

CONTACTLorenzo Berra, MD
lberra@mgh.harvard.edu617-726-3030
PRINCIPAL_INVESTIGATORLorenzo Berra, MD

Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026