RecruitingNot Applicable

Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage

United States, Italy40 participantsStarted 2024-03-03

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Nitric oxide consumption

Timeframe: 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

Timeframe: Daily for 15 days following aneurysmal subarachnoid hemorrhage

Trial details

NCT IDNCT07614906

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-05

Contact for this trial

Lorenzo Berra, MD

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

View on ClinicalTrials.gov More Aneurysmal Subarachnoid Hemorrhage trials