Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) Following Subarachnoid Hemorrhage (SAH)
Completed · Phase 2
Conditions studied: Cerebral Ischemia
In brief
Safety and effect of SANGUINATE on patients DCI following SAH.
Key facts
- Study ID
- NCT02323685
- Run by
- Prolong Pharmaceuticals
- People needed
- 12
- Starts
- 2014-12-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2016-10-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Barnes Jewish Hospital/Washington University — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.