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Safety and Feasibility of Hypertonic Saline Solution After Aneurysmal Subarachnoid Hemorrhage: (HS3)

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ClinicalTrials.gov Identifier: NCT02432157
Recruitment Status : Unknown
Verified February 2016 by Thomas Jefferson University.
Recruitment status was:  Recruiting
First Posted : May 4, 2015
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Cerebral Vasospasm Hyponatremia Drug: HTS 3% Drug: Standard fluid management Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hypertonic Saline Solution in Aneurysmal Subarachnoid Hemorrhage: A Randomized - Phase II Single Blinded Clinical Trial
Study Start Date : January 2015
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Hypertonic saline (HTS)
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.
Drug: HTS 3%
3% HTS at a dose of 250 ml every 6 hours for 7 days

Active Comparator: Standard fluid
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).
Drug: Standard fluid management
Routine fluid management strategy as pre-specified by our SAH management protocol.




Primary Outcome Measures :
  1. Safety (adverse events) [ Time Frame: 21 days ]
    Incidence or proportion of serious adverse events

  2. Feasibility (Proportion of patients treated according to the protocol) [ Time Frame: 21 days ]
    Proportion of patients treated according to the protocol


Secondary Outcome Measures :
  1. Vasospasm (Incidence of cerebral vasospasm defined as clinical deterioration) [ Time Frame: 21 days ]
    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.

  2. Hyponatremia (Incidence of hypovolemic hyponatremia defined as Na <135) [ Time Frame: 21 days ]
    Incidence of hypovolemic hyponatremia defined as Na <135



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432157


Contacts
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Contact: Fred Rincon, MD fred.rincon@jefferson.edu
Contact: Jack Jallo, MD, PhD jack.jallo@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jan Jager, RN    215-955-7301    Jan.Jager@jefferson.edu   
Principal Investigator: Fred Rincon, MD, MSc         
Sponsors and Collaborators
Thomas Jefferson University

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02432157     History of Changes
Other Study ID Numbers: 14D.557
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
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Brain Diseases
Hemorrhage
Subarachnoid Hemorrhage
Hyponatremia
Vasospasm, Intracranial
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Water-Electrolyte Imbalance
Metabolic Diseases