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NCT Number: NCT07614906

Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Nitric oxide metabolite levels

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

    Measurement taken from cerebrospinal fluid

  2. Free hemoglobin

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

    Measurement taken from cerebrospinal fluid

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Berra, MD

CONTACT

[email protected]

617-726-3030

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Registry information

Official study title

Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage (SAH): a Prospective Observational Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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