Acute Anemia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGSANGUINATE™
As needed (PRN) infusions of 500 mL of SANGUINATE
Sponsors
Prolong Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient would otherwise receive RBC transfusion for treatment of severe anemia but cannot (hemolytic/allosensitized or no compatible blood) or will not (religious/personal objection) receive RBCs 2. Hemoglobin ≤ 5 g/dL, or hemoglobin ≤ 7 g/dL following a decline of ≥ 5 g/dL over less than 7 days 3. Age ≥ 18 years 4. Receiving or willing to receive supplemental iron therapy (unless contraindicated) 5. Receiving or willing to receive erythropoiesis-stimulating agent (EPO) therapy 6. Patient or legally authorized representative provided consent to participate 7. Investigator determination that the patient is an appropriate candidate for study enrollment
Exclusion criteria
1. Hemoglobin ≤ 2 g/dL 2. Presence of severe trauma (e.g., Injury Severity Score (ISS)/New Injury Severity Score (NISS) Score ≥ 25) 3. Unable to provide sufficient blood sample volume for screening assessments; or 4. Pregnant; or 5. Investigator determination that the patient is not an appropriate candidate for study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and severity of adverse events within 24-hours of each SANGUINATE infusion | 24 Hours | Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, death and other reported adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who recover from hypoxia-induced abnormal end-organ function | 14 Days | — |
| Percentage of patients who improved with their hemodynamic status | 14 Days | — |
| Percentage of patients who survive the acute episode of severe anemia | 14 Days | — |
| Percentage of patients who discontinue respiratory support/therapy | 14 Days | — |
| Number of serious adverse events following the start of SANGUINATE infusions through the final visit (up to 28 days) | 28 Days | Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, death and other reported serious adverse events |
| Percentage of patients who discontinue inotrope therapy | 14 Days | — |
Countries
United States
Outcome results
None listed