Actively Recruiting
Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage a Prospective Observational Study
Led by Massachusetts General Hospital · Updated on 2026-05-29
40
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
F
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand whether levels of nitric oxide consumption can predict cerebral vasospasm in patients who have suffered an aneurysmal subarachnoid hemorrhage (SAH). The study compares nitric oxide consumption between patients with SAH and those without, using cerebral spinal fluid samples to analyze these levels. This observational study is conducted to explore the potential relationship between nitric oxide use and the occurrence of vasospasm, an important complication of SAH. Participants with SAH will have daily samples of their cerebral spinal fluid collected through an external ventricular drainage system for 15 days following their hemorrhage. These samples will be stored and analyzed to measure nitric oxide consumption. Daily Transcranial Doppler monitoring will check for cerebral vasospasm, and CT angiography will be used when vasospasm is suspected or in comatose patients after four days. A control group of patients undergoing spinal anesthesia without neurological issues will also provide a single cerebral spinal fluid sample during their procedure. Throughout the study, researchers will collect demographic and clinical data from all participants. They will monitor nitric oxide consumption daily for SAH patients and once for controls, alongside assessments for cerebral vasospasm. Secondary measures include nitric oxide metabolite levels and free hemoglobin. Participants are observed for 15 days, with safety and technical monitoring in place. The study aims to classify participants into groups based on the presence or absence of vasospasm and SAH, providing insights into the predictive value of nitric oxide consumption.
CONDITIONS
Brief Title
Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult
- Patient with aneurysmal subarachnoid hemorrhage and an external ventricular drainage placed within 24 hours after the hemorrhage onset
You will not qualify if you...
- Pregnancy
- Pre-existing neurological conditions
- Blood clotting disorders
- Anemia
- Lack of a good cranial window for Transcranial Doppler
- More than 50% stenosis of carotid arteries confirmed by Doppler ultrasound
- Technical problems with external ventricular drainage preventing cerebrospinal fluid collection
- Neurological comorbidities for control patients undergoing spinal anesthesia or vascular surgery with spinal drain placement without neurological issues
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 15 days following hemorrhage
Participants admitted with aneurysmal subarachnoid hemorrhage have daily cerebrospinal fluid samples collected and undergo daily Transcranial Doppler monitoring to assess for cerebral vasospasm.
Daily visits for up to 15 days
Duration - As needed during the 15-day monitoring period
In case of suspected vasospasm or for comatose patients after 4 days, a CT angiography is performed to confirm cerebral vasospasm.
1 to 2 visits depending on vasospasm suspicion
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Italy, 00136
Actively Recruiting
Research Team
L
Lorenzo Berra, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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