Clinical trial NCT02684474: 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
Overall status: AVAILABLE
Conditions: Anemia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: HbO2 Therapeutics LLC
First posted: 2016-02-18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Steven M Frank, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: 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.
citation: 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.