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Expanded Access Protocol Using HBOC-201

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02684474
Expanded Access Status : Available
First Posted : February 18, 2016
Last Update Posted : October 1, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Anemia Biological: HBOC-201

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Intervention Details:
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02684474

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Contact: Steven M Frank, MD 410-955-8465
Contact: Linda MS Resar, MD 410-614-0712

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United States, Maryland
The Johns Hopkins Hospital Available
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University

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Responsible Party: Johns Hopkins University Identifier: NCT02684474    
Other Study ID Numbers: IRB00090805
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Hematologic Diseases
HBOC 201
Blood Substitutes