NO_LONGER_AVAILABLENot Applicable

Expanded Access Protocol Using HBOC-201

United States

Plain-language summary

The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom allogeneic blood transfusion is not an option. HBOC 201 \[hemoglobin glutamer - 250 (bovine)\] has been previously studied as an alternative to blood transfusions in severely anemic patients needing a way to enhance tissue oxygenation. HBOC-201 is purified, cross-linked and polymerized acellular bovine hemoglobin in a modified lactated Ringer's solution, and does not require blood compatibility.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Patients ≥ 18 years of age
✓. 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
✓. Patients or their Legally Authorized Representative who are able and willing to provide informed consent
✓. Blood is not an option due to:

Exclusion criteria

✕. Patients with known hypersensitivity or allergy to beef products
✕. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis\*
✕. Patients who are eligible for blood transfusions
✕. Patients who are \> 80 years old\*

Trial details

NCT IDNCT02684474

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeEXPANDED_ACCESS

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