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