- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02934282
HBOC-201 Expanded Access Protocol for Life-threatening Anemia for Whom Allogeneic Blood Transfusion is Not an Option
Expanded Access Protocol Using HBOC-201
Study Overview
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 Type
Contacts and Locations
Study Contact
- Name: Mauricio Lynn, MD
- Phone Number: 305-585-1178
- Email: mlynn@miami.edu
Study Locations
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Florida
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Miami, Florida, United States, 33136
- Available
- Jackson Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mauricio Lynn, University of Miami
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20160819
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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