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Expanded Access Protocol Using HBOC-201

Primary Purpose

Anemia

Status

Available

Phase

Locations

United States

Study Type

Expanded Access

Intervention

HBOC-201

About this trial

This is an expanded access trial for Anemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

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

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*
- on a case by case and quality of life determination

Sites / Locations

The Johns Hopkins Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT02684474

First Posted

February 10, 2016

Last Updated

September 26, 2023

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT02684474

Brief Title

Expanded Access Protocol Using HBOC-201

Official Title

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

Study Type

Expanded Access

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

HBOC-201

Other Intervention Name(s)

Hemopure

Intervention Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Eligibility Criteria

Inclusion Criteria: 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 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* on a case by case and quality of life determination

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Steven M Frank, MD

Phone

410-955-8465

sfrank3@jhmi.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Linda MS Resar, MD

Phone

410-614-0712

lresar@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven M Frank, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Available

12. IPD Sharing Statement

Citations:

PubMed Identifier

24942198

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.

Results Reference

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PubMed Identifier

25696910

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.

Results Reference

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PubMed Identifier

30474135

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.

Results Reference

background

PubMed Identifier

27473810

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.

Results Reference

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PubMed Identifier

31063596

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.

Results Reference

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PubMed Identifier

31466609

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.

Results Reference

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PubMed Identifier

33857295

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.

Results Reference

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PubMed Identifier

35977366

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.

Results Reference

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PubMed Identifier

36857836

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.

Results Reference

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PubMed Identifier

37624779

Citation

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.

Results Reference

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Expanded Access Protocol Using HBOC-201

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