Acute Anemia Clinical Trial
Official title:
An Open-label Phase 1 Safety Study of SANGUINATE™ Infusion in Patients With Acute Severe Anemia Who Are Unable to Receive Red Blood Cell Transfusion
In this open-label study, eligible and consenting adult patients admitted to the hospital for critical care that have acute severe anemia, defined as a blood hemoglobin level ≤ 5 g/dL, but who are unwilling or unable to receive red blood cell (RBC) transfusion, will receive one or more infusions of SANGUINATE as are deemed necessary by the Investigator for survival of the acute anemic episode.
Data collection for each patient during the in-patient portion of the study will be required
for up to a maximum of 14 days while under critical care, with additional collection of
safety-related findings at 7 days and 14 days after the last infusion of SANGUINATE. Each
patient will thus have up to 28 days participation in the trial.
A minimum of 100 subjects are to be enrolled and to receive at least one infusion of
SANGUINATE, with 14-day follow-up after the last infusion.
Because of the life-threatening effects of severe anemia, it is expected that all patients
in this trial will receive care within a critical care facility (may be called intensive
care or some similar name), wherein all patients will have real-time monitoring of vital
signs and ECG (e.g., by telemetry) before, during, and after all study drug infusions.
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