Expired Study
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St. Louis, Missouri 63110


Purpose:

Safety and effect of SANGUINATE on patients DCI following SAH.


Study summary:

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.


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)


NCT ID:

NCT02323685


Primary Contact:

Study Chair
Michael N Dirringer, MD
Barnes Jewish Hospital/Washington University


Backup Contact:

N/A


Location Contact:

St. Louis, Missouri 63110
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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