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NCT02684474 Clinical Trial

Expanded Access Protocol Using HBOC-201

Anemia Clinical Trial

Official title:
Expanded Access Protocol Using HBOC-201 to Treat Patients With Life Threatening Anemia, for Whom Blood is Not an Option

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT02684474
Other study ID # IRB00090805
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date September 2023
Source Johns Hopkins University
Contact Steven M Frank, MD
Phone 410-955-8465
Email sfrank3@jhmi.edu
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom allogeneic blood transfusion is not an option. HBOC 201 [hemoglobin glutamer - 250 (bovine)] has been previously studied as an alternative to blood transfusions in severely anemic patients needing a way to enhance tissue oxygenation. HBOC-201 is purified, cross-linked and polymerized acellular bovine hemoglobin in a modified lactated Ringer's solution, and does not require blood compatibility.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Patients = 18 years of age 2. Critically ill patients with hemoglobin = 6 g/dL (or 7-8 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 3. Patients or their Legally Authorized Representative who are able and willing to provide informed consent 4. Blood is not an option due to: - refusal of transfusion - lack of compatible red blood cells Exclusion Criteria: 1. Patients with known hypersensitivity or allergy to beef products 2. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis* 3. Patients who are eligible for blood transfusions 4. Patients who are > 80 years old* - on a case by case and quality of life determination

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• HBOC-201
Intravenous administration of a hemoglobin based oxygen carrier (HBOC) in patients with life-threatening anemia, for whom allogeneic blood transfusion is not an option.

Locations
Country Name City State
United States The Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (10)

Asiedu JO, Thomas AJ, Cruz NC, Nicholson R, Resar LMS, Khashab M, Frank SM. Management and clinical outcomes for patients with gastrointestinal bleeding who decline transfusion. PLoS One. 2023 Aug 25;18(8):e0290351. doi: 10.1371/journal.pone.0290351. eCollection 2023. — View Citation

Chaturvedi S, Koo M, Dackiw L, Koo G, Frank SM, Resar LMS. Preoperative treatment of anemia and outcomes in surgical Jehovah's Witness patients. Am J Hematol. 2019 Feb;94(2):E55-E58. doi: 10.1002/ajh.25359. Epub 2018 Dec 18. No abstract available. — View Citation

Cruz NC, Guinn NR, Adegboye J, Hsiao J, Thomas AJ, Lo BD, Chaturvedi S, Resar LMS, Frank SM. A novel algorithm to calculate target preoperative hemoglobin for patients declining allogeneic transfusion. J Clin Anesth. 2023 Aug;87:111070. doi: 10.1016/j.jclinane.2023.111070. Epub 2023 Feb 27. No abstract available. — View Citation

Frank SM, Chaturvedi S, Goel R, Resar LMS. Approaches to Bloodless Surgery for Oncology Patients. Hematol Oncol Clin North Am. 2019 Oct;33(5):857-871. doi: 10.1016/j.hoc.2019.05.009. Epub 2019 Jul 31. — View Citation

Frank SM, Pippa A, Sherd I, Scott AV, Lo BD, Cruz NC, Hendricks EA, Ness PM, Chaturvedi S, Resar LMS. Methods of Bloodless Care, Clinical Outcomes, and Costs for Adult Patients Who Decline Allogeneic Transfusions. Anesth Analg. 2022 Sep 1;135(3):576-585. doi: 10.1213/ANE.0000000000006114. Epub 2022 Aug 17. — View Citation

Frank SM, Wick EC, Dezern AE, Ness PM, Wasey JO, Pippa AC, Dackiw E, Resar LM. Risk-adjusted clinical outcomes in patients enrolled in a bloodless program. Transfusion. 2014 Oct;54(10 Pt 2):2668-77. doi: 10.1111/trf.12752. Epub 2014 Jun 18. — View Citation

Guinn NR, Resar LMS, Frank SM. Perioperative Management of Patients for Whom Transfusion Is Not an Option. Anesthesiology. 2021 Jun 1;134(6):939-948. doi: 10.1097/ALN.0000000000003763. No abstract available. — View Citation

Resar LM, Frank SM. Bloodless medicine: what to do when you can't transfuse. Hematology Am Soc Hematol Educ Program. 2014 Dec 5;2014(1):553-8. doi: 10.1182/asheducation-2014.1.553. Epub 2014 Nov 18. — View Citation

Resar LM, Wick EC, Almasri TN, Dackiw EA, Ness PM, Frank SM. Bloodless medicine: current strategies and emerging treatment paradigms. Transfusion. 2016 Oct;56(10):2637-2647. doi: 10.1111/trf.13736. Epub 2016 Jul 29. — View Citation

Visagie M, Pearson KR, Purvis TE, Gehrie EA, Resar LMS, Frank SM. Greater anemia tolerance among hospitalized females compared to males. Transfusion. 2019 Aug;59(8):2551-2558. doi: 10.1111/trf.15338. Epub 2019 May 7. — View Citation

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