Expanded Access Protocol Using HBOC-201



Status:Available
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - 80
Updated:9/30/2018
Contact:Steven M Frank, MD
Email:sfrank3@jhmi.edu
Phone:410-955-8465

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

Expanded Access Protocol Using HBOC-201 to Treat Patients With Life Threatening Anemia, for Whom Blood is Not an Option

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.


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
We found this trial at
1
site
Johns Hopkins Hospital
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials