Subarachnoid HemorrhagePhase 1/2HS3NCT02432157
Safety and Feasibility of Hypertonic Saline Solution After Aneurysmal Subarachnoid Hemorrhage:
A Phase 1/2 study testing HTS 3% and Standard fluid management in people with Subarachnoid Hemorrhage and Cerebral Vasospasm, run by Thomas Jefferson University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Cerebral Vasospasm, Hyponatremia
- What is being tested?
- HTS 3% and Standard fluid management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Fred Rincon, MD contact
Jack Jallo, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Jan Jager, RN, 215-955-7301, Jan.Jager@jefferson.edu
Fred Rincon, MD, MSc
About this study
Official title: Hypertonic Saline Solution in Aneurysmal Subarachnoid Hemorrhage: A Randomized - Phase II Single Blinded Clinical Trial
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.
Read the detailed description
This is a prospective, single-center, interventional, randomized, parallel, two-arm (1:1) phase II clinical trial with blinded end-point ascertainment designed to determine the safety and feasibility of a protocol of 3% hypertonic saline (HTS) as a "volume expander" administered within 72-hours of admission and up to 7-days in SAH patients compared to standard fluid management, in individuals with aneurysmal SAH. A common sequela of aneurysmal SAH is vasospasm, which causes significant morbidity and mortality. In addition, 30% of patients with SAH develop hypovolemic hyponatremia (serum sodium [Na] <130mEq/L), predisposing them to develop cerebral ischemia. Current guidelines for the management of aneurysmal SAH recommend: (1) maintaining euvolemia in order to prevent delayed cerebral ischemia (DCI) and (2) using HTS as a treatment option for the prevention and treatment of hypovolemic hyponatremia. Treatment for vasospasm includes induction of hypertension, along with systemic and/or intra-arterial administration of calcium channel blockers, or angioplasty. The investigators will (1) measure the incidence of severe adverse events from our protocol of HTS, (2) measure the incidence of cerebral vasospasm in patients treated with our protocol of HTS as compared to patients treated with standard fluid therapy; and (3) assess the burden of hypovolemic hyponatremia.
- Conditions
- Subarachnoid Hemorrhage, Cerebral Vasospasm, Hyponatremia
- Being tested
- HTS 3%, Standard fluid management
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTS 3%Drug
3% HTS at a dose of 250 ml every 6 hours for 7 days
Standard fluid managementDrug
Routine fluid management strategy as pre-specified by our SAH management protocol.
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic saline (HTS) | Experimental | 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. Receives: Drug: HTS 3% |
| Standard fluid | Active comparator | 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). Receives: Drug: Standard fluid management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (adverse events)
Incidence or proportion of serious adverse events
Measured: 21 days
Feasibility (Proportion of patients treated according to the protocol)
Proportion of patients treated according to the protocol
Measured: 21 days
Secondary outcomes (2)
Vasospasm (Incidence of cerebral vasospasm defined as clinical deterioration)
Incidence of cerebral vasospasm defined as clinical deterioration (focal deficit or decline in Glasgow Coma Scale (GCS) score of >/=2 points by neurological exam), or transcranial doppler (TCD) velocity increase with mean blood flow > 120 cm/sec, or arterial narrowing (mod-sec) on DSA or CTA.
Measured: 21 days
Hyponatremia (Incidence of hypovolemic hyponatremia defined as Na <135)
Incidence of hypovolemic hyponatremia defined as Na <135
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432157
- Sponsor's protocol ID
- 14D.557
- Acronym
- HS3
- Status last verified
- Feb 2016
- First submitted
- 10 Mar 2015
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertonic Saline Solution in Aneurysmal Subarachnoid Hemorrhage: A Randomized - Phase II Single Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT02432157
- Acronym / sponsor ID
- HS3 / 14D.557
- Conditions
- Subarachnoid Hemorrhage, Cerebral Vasospasm, Hyponatremia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-center, interventional, randomized, parallel, two-arm (1:1) phase II clinical trial with blinded end-point ascertainment designed to determine the safety and feasibility of a protocol of 3% hypertonic saline (HTS) as a "volume expander" administered within 72-hours of admission and up to 7-days in SAH patients compared to standard fluid management, in individuals with aneurysmal SAH. A common sequela of aneurysmal SAH is vasospasm, which causes significant morbidity and mortality. In addition, 30% of patients with SAH develop hypovolemic hyponatremia (serum sodium [Na] <130mEq/L), predisposing them to develop cerebral ischemia. Current guidelines for the management of aneurysmal SAH recommend: (1) maintaining euvolemia in order to prevent delayed cerebral ischemia (DCI) and (2) using HTS as a treatment option for the prevention and treatment of hypovolemic hyponatremia. Treatment for vasospasm includes induction of hypertension, along with systemic and/or intra-arterial administration of calcium channel blockers, or angioplasty. The investigators will (1) measure the incidence of severe adverse events from our protocol of HTS, (2) measure the incidence of cerebral vasospasm in patients treated with our protocol of HTS as compared to patients treated with standard fluid therapy; and (3) assess the burden of hypovolemic hyponatremia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertonic saline (HTS) | Experimental | Drug: HTS 3%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. |
| Standard fluid | Active comparator | Drug: Standard fluid managementRoutine 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTS 3%3% HTS at a dose of 250 ml every 6 hours for 7 days | Drug | Hypertonic saline (HTS) |
| Standard fluid managementRoutine fluid management strategy as pre-specified by our SAH management protocol. | Drug | Standard fluid |
Primary outcome
Safety (adverse events)
Time frame: 21 days
Incidence or proportion of serious adverse events
Feasibility (Proportion of patients treated according to the protocol)
Time frame: 21 days
Proportion of patients treated according to the protocol
2 secondary outcomes
Vasospasm (Incidence of cerebral vasospasm defined as clinical deterioration)
Time frame: 21 days
Hyponatremia (Incidence of hypovolemic hyponatremia defined as Na <135)
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Rincon, MD contact
Jack Jallo, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HTS 3% and Standard fluid management in people with Subarachnoid Hemorrhage and Cerebral Vasospasm, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fred Rincon, MD (fred.rincon@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (adverse events) (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2016.