Clincosm LogoSign in Get a demo

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

Sponsor
Mauricio Lynn (Other)
Overall Status
Available
CT.gov ID
NCT02934282
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

This is an open label intermediate-size patient population expanded access IND protocol.

Due to our experience with management of severely anemic patients for whom blood is not an option, we anticipate encountering future patients with life-threatening anemia for whom blood is not an option. Blood is not an option in the following circumstances:

  • refusal of transfusion

  • lack of compatible red blood cells due to alloimmunity

All patients with life-threatening anemia for whom blood is not an option will be treated as per the standard procedure. If those measures are not successful and the life-threatening anemia persists, then at the investigator's discretion treatment with HBOC-201 will then be considered.

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access Protocol Using HBOC-201

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Patients ≥ 18 years of age

    2. 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

    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*

    5. Pregnant

    6. Lactating

    • on a case by case and quality of life determination

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jackson Memorial Hospital Miami Florida United States 33136

    Sponsors and Collaborators

    • Mauricio Lynn

    Investigators

    • Principal Investigator: Mauricio Lynn, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mauricio Lynn, Professor of Surgery, University of Miami
    ClinicalTrials.gov Identifier:
    NCT02934282
    Other Study ID Numbers:
    • 20160819
    First Posted:
    Oct 14, 2016
    Last Update Posted:
    Nov 11, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Anemia
    HBOC 201

    Study Results

    No Results Posted as of Nov 11, 2021