Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia

Study Overview
=================
Brief Summary
-----------------
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

Official Title
-----------------
Expanded Access Protocol for the Treatment Use of HBOC-201

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Biological: HBOC-201


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All subjects<br>all qualifying subjects will receive HBOC-201 (Hemopure) to treat their life-threatening anemia | Biological: HBOC-201<br>* HBOC-201 is purified, cross-linked, acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution.<br>* Other names: Hemopure;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | subjects will receive HBOC-201 to treat life-threatening anemia | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
life-threatening anemia, blood alternative, HBOC