Recruiting
Phase 1
Phase 2

Hypertonic Saline

Sponsor:

Thomas Jefferson University

Code:

NCT02432157

Conditions

Subarachnoid Hemorrhage

Cerebral Vasospasm

Hyponatremia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

HTS 3%

Standard fluid management

Study Details

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.

Conditions

Subarachnoid Hemorrhage

Cerebral Vasospasm

Hyponatremia

Study ID

NCT02432157

Start date

Jan, 2015

Status verified date

Feb, 2016

Primary completion date

Jan, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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).

Interventions

HTS 3%

3% HTS at a dose of 250 ml every 6 hours for 7 days

Standard fluid management

Routine fluid management strategy as pre-specified by our SAH management protocol.

Primary outcome measure

  • Safety (adverse events) [ Time Frame: 21 days ]
  • Feasibility (Proportion of patients treated according to the protocol) [ Time Frame: 21 days ]

Central Contacts and Locations

Central contacts

Jack Jallo, MD, PhD

jack.jallo@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Principal Investigator:

Fred Rincon, MD, MSc

More Information

Sponsor

Thomas Jefferson University

Last update posted

Feb 11, 2016

Last verified

Feb, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2016-02-11.