Expanded Access Protocol Using HBOC-201

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

Sponsors

Lead Sponsor: Johns Hopkins University

Source Johns Hopkins University
Brief 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.

Overall Status Available
Study Type Expanded Access
Condition
Intervention

Intervention Type: Biological

Intervention Name: HBOC-201

Description: 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

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, 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

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Overall Official
Last Name Role Affiliation
Steven M Frank, MD Principal Investigator Johns Hopkins University
Overall Contact

Last Name: Steven M Frank, MD

Phone: 410-955-8465

Email: [email protected]

Location
Facility: Status: The Johns Hopkins Hospital
Location Countries

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Condition Browse
Source: ClinicalTrials.gov