Clinical trial NCT02323685: Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) Following Subarachnoid Hemorrhage (SAH)
Official title: Single Escalating-dose, Open-label Study to Assess the Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) After Acute Aneurysmal Subarachnoid Hemorrhage (SAH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Ischemia
Keywords: DCI
Delayed Cerebral Ischemia
SAH
Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage
Cerebral Ischemia
Brain Ischemia
Lead sponsor: Prolong Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-12-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Safety and effect of SANGUINATE on patients DCI following SAH.

Detailed description: The purpose of this study is to study the safety and effect of SANGUINATE on patients suffering from delayed cerebral ischemia after acute aneurysmal subarachnoid hemorrhage.

Eligibility criteria: Inclusion Criteria:

* Signed and dated written informed consent by the subject or his/her legally authorized representative;
* Modified Rankin (mRankin) score of 0 or 1 prior to the onset of subarachnoid hemorrhage;
* Ruptured aneurysm secured by endovascular coil embolization or surgical clipping (the Procedure), not more than 72 hours after the onset of subarachnoid hemorrhage; and
* Hunt and Hess (H\&H) grade 3 or 4, or World Federation of Neurological Surgeons (WFNS) score 3 or 4 prior to the Procedure, and Modified Fisher (mFisher) grade 3 or 4, prior to the Procedure; or
* Clinical signs of ("symptomatic") delayed cerebral ischemia; or
* Angiographic evidence of cerebral vasospasm

Exclusion Criteria:

* In the judgment of the Investigator the patient is not a good candidate for the study
* Evidence of rebleed following the Procedure
* Subarachnoid hemorrhage secondary to trauma or to arteriovenous malformation
* Diagnosed moderate to severe pulmonary hypertension
* Radiologically confirmed moderate to severe pulmonary edema (as shown by the presence of Kerley lines, peribronchial cuffing, thickened interlobar fissure, consolidation and/or pleural effusion)
* History within the past 6 months and/or finding of decompensated heart failure
* Acute myocardial infarction within 3 months prior to the administration of the study drug
* Left ventricular ejection fraction \<40%, as determined by prior echocardiography or clinical signs of CHF
* Medical history or concurrent evidence of moderate to severe renal insufficiency (estimated creatinine clearance \< 30 mL/min)

Primary outcomes:
measure: Safety of study drug during and following infusion as measured by vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events
timeFrame: Up to 30 days
measure: Impact of SANGUINATE on brain oxygenation and blood flow assessed using Postitron Emission Tomography (PET)
timeFrame: Up to 30 days
Secondary outcomes:
measure: Changes in neurological function measured by National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Up to 30 days
measure: Incidence, location, and size of cerebral infarction as measured by MRI
timeFrame: Up to 30 days
measure: Changes in Blood Gases as measured by Hemoximetry
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Barnes Jewish Hospital/Washington University
state: Missouri
Study officials:
affiliation: Barnes Jewish Hospital/Washington University
name: Michael N Dirringer, MD
role: STUDY_CHAIR
affiliation: Barnes Jewish Hospital/Washington University
name: Rajat Dhar, MD
role: PRINCIPAL_INVESTIGATOR
References: