Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage

NCT07614906 | Recruiting

• 1 other identifier: 2023P003051
• Study Type: observational
• Target: 40
• Locations: 2 countries
• Sites: 2

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).

Conditions

Aneurysmal Subarachnoid Hemorrhage; Cerebral Vasospasm

Keywords

Nitric Oxide Consumption

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Nitric oxide metabolite levels

  Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia

• Free hemoglobin

  Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult
• patient with SAH and with an external ventricular drainage (EVD) placed within 24 hours after the onset of the hemorrhage

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00136, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lorenzo Berra, MD

  Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Berra, MD

CONTACT

617-726-3030; lberra@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lorenzo Berra, MD, Assistant Professor, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: March 3, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

IT (1); US (1)