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Hypertonic Saline for Subarachnoid Hemorrhage (HS3 Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights
HS3 Trial Summary
This trial will evaluate if a protocol using hypertonic saline is safe and effective in preventing cerebral vasospasm for patients who have suffered a subarachnoid hemorrhage.
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.Check my eligibility
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.See study design
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.
HS3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
HS3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility (Proportion of patients treated according to the protocol)
Safety (adverse events)
Secondary outcome measures
Hyponatremia (Incidence of hypovolemic hyponatremia defined as Na <135)
Vasospasm (Incidence of cerebral vasospasm defined as clinical deterioration)
HS3 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).
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Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,664 Total Patients Enrolled
1 Trials studying Subarachnoid Hemorrhage
52 Patients Enrolled for Subarachnoid Hemorrhage
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a known seizure disorder.You have blood clotting or bleeding problems, as shown by specific test results.You have another very serious injury that could make it hard for you to stay alive during the study.Your Glasgow Coma Scale score is between 4 and 15.You must have at least one pupil that responds to light.My brain scan shows an aneurysm.My kidney function is impaired.I do not have serious heart, liver, or lung conditions that would make treatment unsafe for me.I am between 18 and 70 years old.I have or need a central line placed for treatment.My Hunt-Hess score is between 1 and 5.I have a spinal cord injury or another serious injury.My heart's pumping ability is significantly reduced.You need to have a normal head CT scan, or a CT scan that shows a type of bleed that is not subarachnoid hemorrhage.I do not have a brain disease or major psychiatric disorder.You have a brain scan showing subarachnoid hemorrhage.Your blood sodium level is higher than 155 mEq/L.I can start treatment within 3 days of my symptoms appearing.My brain hemorrhage is classified between grades 1 to 4.
Research Study Groups:
This trial has the following groups:- Group 1: Standard fluid
- Group 2: Hypertonic saline (HTS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment available for this clinical trial?
"Results on the clinicaltrials.gov platform suggests that this trial is not actively recruiting participants, despite being posted originally in January 2015 and last updated February 2016. Although no candidates are currently being sought, there are 371 other trials seeking enrolment at present."
Answered by AI
Does the protocol for this clinical trial extend to those aged below sixty?
"The enrollment requirements for this trial dictate that those applying must be at least 18 years old and no older than 70."
Answered by AI
Am I eligible to join this research endeavor?
"This trial seeks to enrol 50 patients aged 18-70 that are currently suffering from vasospasm, cerebral. Eligible candidates must possess one responsive pupil, a prerequisite for central line placement, and an Hunt-Hess score of 1-5 in combination with a Glascow Come Scale rating between 4 and 15."
Answered by AI
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