Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT07614906

Conditions

Aneurysmal Subarachnoid Hemorrhage

Cerebral Vasospasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT07614906

Start date

Mar 3, 2024

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Nitric oxide consumption [ Time Frame: 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 [ Time Frame: Daily for 15 days following aneurysmal subarachnoid hemorrhage ]

Central Contacts and Locations

Central contacts

Lorenzo Berra, MD

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Lorenzo Berra, MD

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

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Nitric Oxide Consumption

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-29.