Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) Following Subarachnoid Hemorrhage (SAH)

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)

Safety and effect of SANGUINATE on patients DCI following SAH.

Study Overview

• Status: Completed
• Conditions: Cerebral Ischemia
• Intervention / Treatment: Biological: SANGUINATE™

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital/Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SANGUINATE™; Single infusion of SANGUINATE (pegylated carboxyhemogloblin)	Biological: SANGUINATE™; Single infusion of SANGUINATE (pegylated carboxyhemogloblin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of study drug during and following infusion as measured by vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events	Safety assessments to include vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events	Up to 30 days
Impact of SANGUINATE on brain oxygenation and blood flow assessed using Postitron Emission Tomography (PET)	Blood oxygenation and blood flow will be assessed using Postitron Emission Tomography (PET)	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in neurological function measured by National Institutes of Health Stroke Scale (NIHSS)	Up to 30 days
Incidence, location, and size of cerebral infarction as measured by MRI	Up to 30 days
Changes in Blood Gases as measured by Hemoximetry	Up to 30 days

Collaborators and Investigators

• Sponsor: Prolong Pharmaceuticals
• Investigators: Study Chair: Michael N Dirringer, MD, Barnes Jewish Hospital/Washington University; Principal Investigator: Rajat Dhar, MD, Barnes Jewish Hospital/Washington University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: November 12, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (ESTIMATE): December 23, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: SAH; Subarachnoid Hemorrhage; Brain Ischemia; Aneurysmal Subarachnoid Hemorrhage; Cerebral Ischemia; DCI; Delayed Cerebral Ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Stroke; Brain Infarction; Intracranial Hemorrhages; Brain Ischemia; Ischemia; Hemorrhage; Cerebral Infarction; Subarachnoid Hemorrhage
• Other Study ID Numbers: SGCI-002