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Recruiting NCT07614906

Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage

— Observational Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston
Italy · 1 center
  • Fondazione Policlinico Universitario Agostino Gemelli — Rome

Identifiers

NCT: NCT07614906 · 2023P003051

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗