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

Cerebral Ischemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323685
• Other study ID #: SGCI-002
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2014
• Last updated: October 26, 2016
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Prolong Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Safety and effect of SANGUINATE on patients DCI following SAH.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia
• Hemorrhage
• Ischemia
• Subarachnoid Hemorrhage

Intervention

Biological:
• SANGUINATE™
Single infusion of SANGUINATE (pegylated carboxyhemogloblin)

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital/Washington University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Prolong Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	Changes in neurological function measured by National Institutes of Health Stroke Scale (NIHSS)		Up to 30 days	No
Secondary	Incidence, location, and size of cerebral infarction as measured by MRI		Up to 30 days	No
Secondary	Changes in Blood Gases as measured by Hemoximetry		Up to 30 days	No