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

Primary Purpose

Anemia

Status

Available

Phase

Locations

United States

Study Type

Expanded Access

Intervention

HBOC-201

About this trial

This is an expanded access trial for Anemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Jackson Memorial Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT02934282

First Posted

October 4, 2016

Last Updated

November 14, 2022

Sponsor

Mauricio Lynn

1. Study Identification

Unique Protocol Identification Number

NCT02934282

Brief Title

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

Official Title

Expanded Access Protocol Using HBOC-201

Study Type

Expanded Access

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mauricio Lynn

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

HBOC-201

Other Intervention Name(s)

hemoglobin glutamer - 250 (bovine)

Intervention Description

Hemoglobin Based Oxygen Carrier (HBOC)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mauricio Lynn, MD

Phone

305-585-1178

mlynn@miami.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mauricio Lynn

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jackson Memorial Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Available

12. IPD Sharing Statement

Learn more about this trial

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

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