The purpose of this protocol is to provide treatment with HBOC-201 to patients withlife-threatening anemia for whom allogeneic blood transfusion is not an option. HBOC 201[hemoglobin glutamer - 250 (bovine)] has been previously studied as an alternative toblood transfusions in severely anemic patients needing a way to enhance tissueoxygenation. HBOC-201 is purified, cross-linked and polymerized acellular bovinehemoglobin in a modified lactated Ringer's solution, and does not require bloodcompatibility.
Not Provided
Biological: HBOC-201
Intravenous administration of a hemoglobin based oxygen carrier (HBOC) in patients with
life-threatening anemia, for whom allogeneic blood transfusion is not an option.
Other Name: Hemopure
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,
circulatory hypervolemia or systemic mastocytosis*
3. Patients who are eligible for blood transfusions
4. Patients who are > 80 years old*
- on a case by case and quality of life determination
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Steven M Frank, MD
410-955-8465
sfrank3@jhmi.edu
Linda MS Resar, MD
410-614-0712
lresar@jhmi.edu
Steven M Frank, MD, Principal Investigator
Johns Hopkins University