What side effects are associated with this type of intervention?

Common treatments for subarachnoid hemorrhage (SAH) include the use of hypertonic saline (HTS) for volume expansion to enhance brain circulation and prevent cerebral vasospasm. The known side effects of HTS include electrolyte imbalances, such as hypernatremia, and potential complications related to fluid overload, such as pulmonary edema. Other treatments for SAH, such as nimodipine, can cause hypotension and gastrointestinal disturbances. Invasive procedures like surgical clipping or endovascular coiling may lead to complications such as infection, bleeding, or vessel damage. Overall, while these treatments are essential for managing SAH, they carry risks that need to be carefully monitored.

What prior FDA approvals exist?

The FDA has approved several treatments for Subarachnoid Hemorrhage (SAH), primarily focusing on preventing complications such as cerebral vasospasm. Nimodipine, a calcium channel blocker, is one such drug that has been approved to reduce the incidence and severity of ischemic deficits in patients with SAH. While the use of Hypertonic Saline (HTS) for volume expansion to enhance brain circulation is being studied, it is not explicitly mentioned as an FDA-approved treatment in the provided context. Current treatments aim to manage symptoms and prevent secondary complications rather than directly using volume expansion techniques.

What other types of research exist?

Promising novel alternatives to hypertonic saline for subarachnoid hemorrhage patients include the use of nimodipine, a calcium channel blocker that has been shown to reduce the incidence and severity of cerebral vasospasm. Additionally, magnesium sulfate is being investigated for its neuroprotective properties and potential to improve outcomes in SAH patients. Endovascular treatments, such as intra-arterial vasodilators (e.g., verapamil or nicardipine) and balloon angioplasty, are also emerging as effective strategies to manage cerebral vasospasm and enhance brain circulation.

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Hypertonic Saline for Subarachnoid Hemorrhage (HS3 Trial)

Q: What is the mechanism of action of this treatment?

Hypertonic saline (HTS) is used in the treatment of subarachnoid hemorrhage (SAH) primarily to prevent cerebral vasospasm, a condition where the brain's arteries constrict, potentially leading to stroke and poor outcomes. HTS works by increasing the osmolarity of the blood, which helps to draw fluid out of the brain tissue and reduce cerebral edema. This volume expansion enhances cerebral circulation, ensuring better oxygen and nutrient delivery to the brain. For SAH patients, this is crucial as it helps to maintain adequate cerebral perfusion and prevent secondary ischemic injuries, thereby improving overall prognosis.

Phase 1 & 2

Waitlist Available

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

DSA (digital subtraction angiogram) or CTA confirmed presence of intracranial aneurysm

Age 18 to 70 inclusive

Must not have

Known seizure disorder

Renal insufficiency (baseline Cr>1.5 mg/dl, CrCl<30 ml/min, CKD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a strong saltwater solution can safely and effectively prevent blood vessel narrowing in the brain for patients with bleeding from a ruptured aneurysm. The goal is to improve blood flow and reduce the risk of stroke. This solution has been investigated in various strengths for treating high pressure in the brain and has shown effectiveness in reducing severe pressure without adverse effects.

Who is the study for?

This trial is for adults aged 18-70 with a recent subarachnoid hemorrhage (SAH) confirmed by brain scans and tests, who can start treatment within 72 hours of symptoms. They should have some level of consciousness and not be pregnant or have severe non-brain injuries, significant heart, liver, lung diseases, kidney issues, known brain disease other than SAH or major psychiatric disorders.

What is being tested?

The study is testing the safety and effectiveness of using Hypertonic Saline Solution (HTS) to prevent cerebral vasospasm—a dangerous narrowing of brain arteries—after an SAH. Participants will receive HTS as part of their fluid management to see if it improves blood flow in the brain compared to standard care.

What are the potential side effects?

Potential side effects from HTS may include increased thirst, swelling due to fluid retention, high sodium levels in the blood which can cause confusion or seizures if severe. Standard fluid management risks are generally low but could include electrolyte imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain scan shows an aneurysm.

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I am between 18 and 70 years old.

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I have or need a central line placed for treatment.

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My Hunt-Hess score is between 1 and 5.

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My brain hemorrhage is classified between grades 1 to 4.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a known seizure disorder.

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My kidney function is impaired.

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I have a spinal cord injury or another serious injury.

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My heart's pumping ability is significantly reduced.

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I do not have a brain disease or major psychiatric disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility (Proportion of patients treated according to the protocol)

Safety (adverse events)

Secondary study objectives

Hyponatremia (Incidence of hypovolemic hyponatremia defined as Na <135)

Vasospasm (Incidence of cerebral vasospasm defined as clinical deterioration)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hypertonic saline (HTS)Experimental Treatment1 Intervention

A protocol of prophylactic 3% HTS as a volume expander with bolus (over 30 minutes) of 3% HTS at a dose of 250 ml every 6 hours for 7 days. This will be given through a central line as soon as possible and within 72 hours of onset of SAH symptoms.

Group II: Standard fluidActive Control1 Intervention

Routine fluid management strategy as pre-specified by our SAH management protocol at Jefferson University Hospital according to the American Heart Association and Neurocritical Care Guidelines for the management of SAH (this includes conventional intravenous fluids or normal saline solutions to maintain a normal hydration status and guided by the treating doctor and daily assessments of fluid balance).

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hypertonic saline (HTS) is used in the treatment of subarachnoid hemorrhage (SAH) primarily to prevent cerebral vasospasm, a condition where the brain's arteries constrict, potentially leading to stroke and poor outcomes. HTS works by increasing the osmolarity of the blood, which helps to draw fluid out of the brain tissue and reduce cerebral edema. This volume expansion enhances cerebral circulation, ensuring better oxygen and nutrient delivery to the brain. For SAH patients, this is crucial as it helps to maintain adequate cerebral perfusion and prevent secondary ischemic injuries, thereby improving overall prognosis.