Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult
patient with SAH and with an external ventricular drainage (EVD) placed within 24 hours after the onset of the hemorrhage
Disqualifiers
pregnancy
pre-existing neurological comorbidities
coagulation disorders
anemia
Trial population
The cohort of patients with SAH will be selected from patients in the Intensive Care Unit at Gemelli Hospital in Rome, Italy, within 24 hours after the onset of the hemorrhage and with an external ventricular drain. The control group will be patients at Massachusetts General Hospital who are undergoing spinal anesthesia in the operating room, or those with a spinal drain for major vascular surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Aneurysmal subarachnoid hemorrhage
Group B: Control
Trial outcomes
Primary outcomes
1
Nitric oxide consumption
Measurement taken from cerebrospinal fluid using nitric oxide consumption analyzer
Time frame
Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia2
Occurrence of cerebral vasospasm in patients with 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.
Time frame
Daily for 15 days following aneurysmal subarachnoid hemorrhageSecondary outcomes
1
Nitric oxide metabolite levels
Measurement taken from cerebrospinal fluid
Time frame
Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia2
Free hemoglobin
Measurement taken from cerebrospinal fluid
Time frame
Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesiaSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Source ClinicalTrials.gov