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

Prolong Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Cerebral Ischemia

Treatments: Biological: SANGUINATE™

Study type: Interventional

Funder types: Industry

Identifiers

NCT02323685

SGCI-002

Details and patient eligibility

About

Safety and effect of SANGUINATE on patients DCI following SAH.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

12 participants in 1 patient group

SANGUINATE™

Experimental group

Description:

Single infusion of SANGUINATE (pegylated carboxyhemogloblin)

Treatment:

Biological: SANGUINATE™