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

NCT02432157 | Unknown Phase 1 DMC

• 1 other identifier: 14D.557
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Safety (adverse events)

  Incidence or proportion of serious adverse events

  21 days

• Feasibility (Proportion of patients treated according to the protocol)

  Proportion of patients treated according to the protocol

  21 days

Secondary Outcomes (2)

• Vasospasm (Incidence of cerebral vasospasm defined as clinical deterioration)

  21 days

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

  21 days

Study Arms (2)

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.

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).

Drug: Standard fluid management

Interventions

HTS 3% DRUG

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

Hypertonic saline (HTS)

Standard fluid management DRUG

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

Standard fluid

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial; Hyponatremia

Interventions

5-(3-hydroxybenzoyl)-2-thiophenesulfonamide

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Fred Rincon, MD

CONTACT

fred.rincon@jefferson.edu

Jack Jallo, MD, PhD

CONTACT

jack.jallo@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: May 4, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Last Updated: February 11, 2016

Record last verified: 2016-02

Locations

US (1)