HBOC-201 Expanded Access Protocol for Life-threatening Anemia for Whom Allogeneic Blood Transfusion is Not an Option

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Conditions studied: Anemia

In brief

The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option. Such patients may also be referred to in this document as patients who refuse blood transfusion (PWRBT). Other patients who potentially may require HBOC-201 treatment include those with red blood cell alloantibodies for whom immunologically compatible red blood cell units cannot be found, although these patients are less common than PWRBT.

Key facts

Study ID: NCT02934282
Run by: Mauricio Lynn
Last updated by the study team: 2024-12-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients ≥ 18 years of age
Critically ill patients with hemoglobin < 5 g/dL (or 6-7 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:
refusal of transfusion
lack of compatible red blood cells

You may not qualify if…

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*
Pregnant
Lactating
on a case by case and quality of life determination

Where it is running

Jackson Memorial Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

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