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No Longer Available NCT03633604

Expanded Access IND Administration of HBOC-201 in Patients With Severe Acute Anemia

Conditions: Anemia Severe

Sex: All
Ages: 18 Years – 80 Years
Sponsor: Michael Boisen

Location: University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Summary

HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, or reduce the need for red blood cell transfusions in anemic patients This is an expanded access IND protocol, and will provide treatment with HBOC-201 to severely anemic adults for whom blood is not an option

Eligibility Criteria

Inclusion Criteria: 1. Patients ≥ 18 years of age 2. Critically ill patients with hemoglobin ≤ 6 g/dL (or 7-8 g/dL with significant active bleeding), and physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or evidence of central nervous system acute deficits 3. Patients or their Legally Authorized Representative who are able and willing to provide informed consent 4. Blood is not an option due to: * refusal of transfusion * lack of compatible red blood cells Exclusion Criteria: 1. Patients with known hypersensitivity or allergy to beef products 2. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure (caution should be exercised if renal insufficiency is present), circulatory hypervolemia or systemic mastocytosis\* 3. Patients who are eligible for blood transfusions 4. Patients who are \> 80 years old\* 5. Pregnant or lactating women * on a case by case and quality of life determination

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03633604). StuddyBuddy aggregates publicly available trial information.