Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HBOC-201.
- Who it may be relevant to
- Registry conditions: Anemia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Expanded Access Protocol for the Treatment Use of HBOC-201
Overview
The purpose of this expanded access study is to be able to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option. HBOC-201 is not FDA approved for use in the United States, but is approved as an oxygen carrier in South Africa and Russia.
Detailed description
i. Initial Dose
For patients with a hemoglobin level less than 6 mg/dl, an initial dose of 32.5 g (one unit) of HBOC 201 is recommended, to be followed by infusion of additional units as necessary to achieve and maintain a total hemoglobin concentration above 6 g/dl, provided that the patient's circulatory volume is properly controlled and will not impose an inappropriate risk.
ii. Subsequent Doses
The need for additional dose administration should be assessed after each infusion as clinically indicated.
Dosing will be stopped if any one of the following occurs:
* resolution of critical ischemia * death * recovery of native Hemoglobin levels to \> 6 g/dL, * evidence of reticulocytosis
Interventions
- Biological HBOC-201
HBOC-201 is purified, cross-linked, acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution.
Primary outcome measures
- survival [Time frame: 1 week]
Eligibility criteria
Inclusion criteria
- Patients > = 18 years of age
- Patients with hemoglobin < = 8g/dL with with active bleeding, physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or central nervous system supply dependency
- Patients or their Legally Authorized Representatives who are able and willing to provide informed consent
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 (on a case by case and quality of life determination)
- Patients > 80 years of age (on a case by case and quality of life determination)
- Patients who are eligible for blood transfusions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Englewood Hospital and Medical Center — Englewood
Identifiers
NCT: NCT01881503 · E-12-454