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

NCT02934282 | Unknown

• 1 other identifier: 20160819
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Interventions

HBOC-201 DRUG

Hemoglobin Based Oxygen Carrier (HBOC)

Also known as: hemoglobin glutamer - 250 (bovine)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mauricio Lynn: lead

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

HBOC 201

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mauricio Lynn

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 14, 2016
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

US (1)