Expanded Access Protocol Using HBOC-201

NCT02684474 | Unknown

• 1 other identifier: IRB00090805
• 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 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.

Conditions

Anemia

Interventions

HBOC-201 BIOLOGICAL

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

Also known as: Hemopure

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 ≤ 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
• 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\*
• on a case by case and quality of life determination

Sponsors & Collaborators

• Johns Hopkins University: lead
• HbO2 Therapeutics LLC: collaborator

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (12)

• 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.

  PMID: 24942198 BACKGROUND

• 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.

  PMID: 25696910 BACKGROUND

• 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.

  PMID: 30474135 BACKGROUND

• 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.

  PMID: 27473810 BACKGROUND

• 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.

  PMID: 31063596 BACKGROUND

• 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.

  PMID: 31466609 BACKGROUND

• 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.

  PMID: 33857295 BACKGROUND

• 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.

  PMID: 35977366 BACKGROUND

• 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.

  PMID: 36857836 BACKGROUND

• 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.

  PMID: 37624779 BACKGROUND

• Sklar MB, Kajstura TJ, Vogt SL, Gray C, Ulatowski JA, Resar LMS, Frank SM. Gastrointestinal Bleeding and Survival After a Nadir Hemoglobin <3.0 g/dL in 2 Jehovah's Witness Patients: A Case Report. A A Pract. 2024 Aug 13;18(8):e01837. doi: 10.1213/XAA.0000000000001837. eCollection 2024 Aug 1.

  PMID: 39137122 BACKGROUND

• Lo BD, Pippa A, Sherd I, Scott AV, Thomas AJ, Hendricks EA, Ness PM, Chaturvedi S, Resar LMS, Frank SM. Clinical Outcomes, Blood Utilization, and Ethical Considerations for Pediatric Patients in a Bloodless Medicine and Surgery Program. Anesth Analg. 2024 Feb 1;138(2):465-474. doi: 10.1213/ANE.0000000000006776. Epub 2024 Jan 12.

  PMID: 38175737 BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

HBOC 201

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Steven M Frank, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 18, 2016
• Last Updated: October 23, 2025

Record last verified: 2025-10

Locations

US (1)