Safety and Feasibility of Hypertonic Saline Solution After Aneurysmal Subarachnoid Hemorrhage:

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Subarachnoid Hemorrhage, Cerebral Vasospasm, Hyponatremia

In brief

Subarachnoid hemorrhage (SAH) occurs after rupture of cerebral aneurysms. Treatment of SAH focuses on avoiding medical complications including cerebral vasospasm, which may result in limited circulation to the brain. Cerebral vasospasm, or thinning of the arteries of the brain, is a feared complication that could potentially cause stroke and worst outcomes after SAH. Hypertonic saline (HTS) is a compound that may be used to prevent vasospasm following SAH by enhancing the circulation in the brain. This study will evaluate if a protocol of volume expansion with HTS is safe and effective in patients with subarachnoid hemorrhage for the prevention of cerebral vasospasm.

Key facts

Study ID

NCT02432157

Run by

Thomas Jefferson University

People needed

50

Starts

2015-01-01

Last updated by the study team

2016-02-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 70 inclusive
• Hunt-Hess score of 1-5
• Glascow Come Scale 4-15
• Modified Fisher Grade 1-4
• At least one reactive pupil
• A brain CT/ MRI demonstrating SAH
• DSA (digital subtraction angiogram) or CTA confirmed presence of intracranial aneurysm
• The patient can be started on HTS within 72 hours of onset of symptoms of SAH
• Previously placed central line or having other indication for central line placement

You may not qualify if…

• Pregnancy, or inability to rule out pregnancy with a pregnancy test
• A normal head CT scan or a CT scan showing a bleed that is not SAH
• Spinal cord injury or other serious noncerebral injury
• Known seizure disorder
• Known brain disease (eg tumor, metastasis) or major psychiatric disorders (eg schizophrenia)
• Renal insufficiency (baseline Cr>1.5 mg/dl, CrCl<30 ml/min, CKD)
• Acute systolic dysfunction or congestive heart failure (CHF), with EF <30%
• Hematologic abnormalities or coagulopathy (PT>20, PTT>50, INR>1.5, or bleeding time>10sec)
• Clinically significant cardiovascular, hepatic or pulmonary disease that, in the opinion of the investigator, would compromise patient safety
• Other life-threatening injury that compromises patient survival through duration of study
• Patient unlikely to be available for follow-up at 6 months after trial conclusion
• Any concurrent relevant condition that makes the patient unsuitable for participation or follow-up
• Serum sodium > 155 mEq/L

Where it is running

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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