Aneurysmal Subarachnoid HemorrhageNCT07614906
Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage
An observational study of Aneurysmal Subarachnoid Hemorrhage and Cerebral Vasospasm, run by Massachusetts General Hospital at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Mar 2024to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adult
- patient with SAH and with an external ventricular drainage (EVD) placed within 24 hours after the onset of the hemorrhage
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Lorenzo Berra, MD, 617-726-3030, lberra@mgh.harvard.edu
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Rome, 00136
Valentina Giammatteo, MD
About this study
Official title: Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage (SAH): a Prospective Observational Study
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).
Read the 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
- Keywords
- Nitric Oxide Consumption
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nitric oxide consumption
Measurement taken from cerebrospinal fluid using nitric oxide consumption analyzer
Measured: 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.
Measured: Daily for 15 days following aneurysmal subarachnoid hemorrhage
Secondary outcomes (2)
Nitric oxide metabolite levels
Measurement taken from cerebrospinal fluid
Measured: Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
Free hemoglobin
Measurement taken from cerebrospinal fluid
Measured: Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start3 Mar 2024
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Berra, MD, Massachusetts General Hospital
- Investigators
- Lorenzo Berra, MD, Principal investigator, Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614906
- Sponsor's protocol ID
- 2023P003051
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage (SAH): a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07614906
- Acronym / sponsor ID
- 2023P003051
- Keywords
- Nitric Oxide Consumption
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult
- patient with SAH and with an external ventricular drainage (EVD) placed within 24 hours after the onset of the hemorrhage
Key exclusion criteria (8 listed)
- pregnancy
- pre-existing neurological comorbidities
- coagulation disorders
- anemia
- absence of a good cranial window to perform Transcranial Doppler (TDC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nitric oxide consumption
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
Occurrence of cerebral vasospasm in patients with subarachnoid hemorrhage
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.
2 secondary outcomes
Nitric oxide metabolite levels
Time frame: Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
Free hemoglobin
Time frame: Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorenzo Berra, MD principal investigator
Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmal Subarachnoid Hemorrhage and Cerebral Vasospasm, run by Massachusetts General Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Berra, MD (617-726-3030, lberra@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nitric oxide consumption (time frame: Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.