Users guide to pitfalls and lessons learned about HBOC-201 during clinical trials, expanded access, and clinical use in 1,701 patients

Shock

Volumn 52, Issue 1S, 2019, Pages 92-99

  MacKenzie, Colin F ^a   Dubé, Gregory P ^b   Pitman, Arkaidy ^b   Zafirelis, Melissa ^b  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b HbO2 Therapeutics   (United States)

Author keywords

Acute anemia management; adverse events; bloodless surgery; educational training; hemoglobin based oxygen carriers; humans; transfusion avoidance

Indexed keywords

CALCIUM CHANNEL BLOCKING AGENT; CREATININE; FUROSEMIDE; GLYCERYL TRINITRATE; HEMOGLOBIN; HETASTARCH; METHEMOGLOBIN; PANCREAS ENZYME; PLACEBO; POLYMERIZED HEMOGLOBIN; SPASMOLYTIC AGENT; BLOOD SUBSTITUTE; OXYGEN;

ABDOMINAL PAIN; ADVERSE DRUG REACTION; BLOOD TRANSFUSION; CAUSE OF DEATH; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL (TOPIC); COMPASSIONATE USE; DIARRHEA; DISEASE DURATION; DRUG ANTIGENICITY; DRUG USE; DYSPHAGIA; ELEVATED BLOOD PRESSURE; ERYTHROCYTE; ERYTHROCYTE TRANSFUSION; FLATULENCE; GASTROINTESTINAL SYMPTOM; HALF LIFE TIME; HEALTH PROGRAM; HEART DISEASE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; LIVER FAILURE; MANAGED CARE; MEDICAL EDUCATION; MORTALITY RATE; MULTICENTER STUDY (TOPIC); NAUSEA; OLIGURIA; PANCREATITIS; PHARMACOKINETIC PARAMETERS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PLASMA VOLUME; PULSE OXIMETRY; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SCLERA DISEASE; SHELF LIFE; SIDE EFFECT; SKIN DISCOLORATION; SURVIVAL RATE; SYSTOLIC BLOOD PRESSURE; TREATMENT FAILURE; VOMITING; BLOOD; BLOOD PRESSURE; INJURY; METABOLISM; OXIMETRY; PHYSIOLOGY;

BLOOD PRESSURE; BLOOD SUBSTITUTES; COMPASSIONATE USE TRIALS; HEMOGLOBINS; HUMANS; OXIMETRY; OXYGEN; WOUNDS AND INJURIES;

EID: 85046155083     PISSN: 10732322     EISSN: 15400514     Source Type: Journal    
DOI: 10.1097/SHK.0000000000001038     Document Type: Review

References (34)

1. Natanson C, Kern SJ, Lurie P, Banks SM, Wolfe SM: Cell-free hemoglobinbased blood substitutes and risk of myocardial infarction and death: A metaanalysis. JAMA 299:2304-2312, 2008.
2. Silverman TA, Weiskopf RB: Hemoglobin based oxygen carriers: Current status and future directions. Transfusion 49:2495-2515, 2009.
3. Expanded Access to Investigational Drugs for Treatment Use. Available at: Https://www.fda.gov/downloads/drugs/guidances/ucm351261.pdf (accessed July 27, 2017).
4. Dube GP, Vranckx P, Greenburg AG: HBOC-201: The multi-purpose oxygen therapeutic. EuroIntervention 4:161-165, 2008.
5. Jahr JS, Mackenzie C, Pearce LB, Pitman A, Greenburg AG: HBOC-201 as an alternative to blood transfusion: Efficacy and safety evaluation in a multicenter phase III trial in elective orthopedic surgery. J Trauma 64:1484-1492, 2008.
6. Posluszny JA, Napolitano LM: How do we treat life-threatening anemia in a Jehovah's Witness patient Transfusion 54:3026-3034, 2014.
7. Fronticelli C, Bucci E, Orth C: Solvent regulation of oxygen affinity in hemoglobin. Sensitivity of bovine hemoglobin to chloride ions. J Biol Chem 259:10841-10844, 1984.
8. Cohen RM, Franco RS, Khera PK: Red cell life span heterogeneity in hematologically normal people is sufficient to alter HbA1c. Blood 112(10):4284-4291, 2008.
9. Levien LJ: South Africa: Clinical experience with Hemopure. ISBT Sci Ser 1:167-173, 2006.
10. Expanded Access Study of HBOC-201 (Hemopure) for the treatment of life-threatening anemia. Available at: Https://clinicaltrials.gov/ct2/show/NCT01881503 (accessed July, 27, 2017).
11. Naval Medical Research Center's Briefing Book for 14 December 2006 Blood Product advisory Committee (BPAC) Meeting, pp. 84-100. Available at: Http://www.fda.gov/ohrms/docket/ac/06/slides/2006-4270S 9.ppt (accessed May 17, 2017).
12. Hamilton RG, Kickler TS: Bovine hemoglobin (glutamer-250, Hemopure)-specific immunoglobulin G antibody cross-reacts with human hemoglobin but does not lyse red blood cells in vitro. Transfusion 47:723-728, 2007.
13. Van Hemelrijck J, Levien LJ, Veeckman L, Pitman A, Zafirelis Z, Standl T: A safety and efficacy evaluation of hemoglobin-based oxygen carrier HBOC-201 in a randomized, multicenter red blood cell controlled trial in noncardiac surgery patients. Anesth Analg 119:766-776, 2014.
14. Page TC, Light WR, Hellums JD: Oxygen transport by erythrocyte hemoglobin solution mixtures in an in vitro capillary as a model of hemoglobin-based oxygen carrier performance. Microvasc Res 55:54-56, 1998.
15. Pearce LB, Gawryl MS, Rentko VT, Moon-Massat PF, Rausch CW: HBOC-210 (hemoglobin glutamer 250 bovine) Hemopure1: Clinical studies. In: Winslow RM, editor. Blood Substitutes. San Diego, CA: Elsevier; 2006. pp. 438-450, 2006. Chapter 37.
16. Serruys PW, Vranckx P, Slagboom T, Regar E, Meliga E, de Winter RJ, Heyndrickx G, van Remortel EAM, Dube GP, Symons J: Hemodynamic effects, safety, and tolerability of hemoglobin-based oxygen carrier-201 (HBOC-201) in patients undergoing PCI for CAD. EuroIntervention J 3:600-609, 2008.
17. te Lintel Hekkert M, Dube GP, Regar E, de Boer M, Vranckx P, van der Giessen WJ, Serruys PW, Duncker DJ: Pre-oxygenated hemoglobin-based oxygen carrier HBOC-201 annihilates myocardial ischemia during brief coronary artery occlusion in pigs. Am J Physiol Heart Circ Physiol 298:H1103-H1113, 2010.
18. Meliga E, Vranckx P, Regar E, Kint PP, Duncker DJ, Serruys PW: Proof-ofconcept trial to evaluate hemoglobin based oxygen therapeutics in elective percutaneous coronary revascularization. Rationale, protocol design and hemodynamic results. EuroIntervention 4:99-107, 2008.
19. Garca-Ruiz JM, Galan-Arriola C, Fernandez-Jimenez R, Aguero J, Sanchez-Gonzalez J, Garca-Alvarez A, Nuno-Ayala M, Dube GP, Zafirelis Z, Lopez-Martn GJ, et al.: Bloodless reperfusion with the oxygen carrier HBOC-201 in acute myocardial infarction: A novel platform for cardioprotective probes delivery. Basic Res Cardiol 112(2):17, 2017.
20. Mackenzie CF, Moon-Massat PF, Shander A, JavidrooziM, Greenburg AG: When blood is not an option: Factors affecting survival after the use of a hemoglobin-based oxygen carrier in 54 patients with life-threatening anemia. Anesth Analg 110:685-689, 2010.
21. Rehman HU: Methemoglobinemia. West J Med 175:193-197, 2001.
22. Sears DA, Udden MM, Thomas LJ: Carboxyhemoglobin levels in patients with sickle-cell anemia: Relationship to hemolytic and vasooclusive severity. Am J Med Sci 322:345-348, 2001.
23. Yazer MH, Triulzi DJ: ABBB red blood cell transfusion guidelines. Something for almost everyone. JAMA 316:1984-1985, 2016.
24. Thompson G. HBOC-201 treatment in a Jehovah's Witness with auto-immune haemolytic anemia. Soc for the Advancement of Blood Management Poster # 12409. Gaylords Palms Resort and Conference Center, August 27th-30th, Kissimmee, FL. 2008.
25. Fitzgerald MC, Chan JY, Ross AW, Liew SM, ButtWW, Baguley D, Salem HH, Russ MK, Deasy C, Martin KE, et al.: A synthetic haemoglobin-based oxygen carrier and the reversal of cardiac hypoxia secondary to severe anaemia following trauma. Med J Aust 194(9):471-473, 2011.
26. Weiskopf RB, Beliaev AB, Shander A, Guinn NR, Cap AP, Ness PM, Silverman TA: Addressing the unmet need of life-threatening anemia with hemoglobinbased oxygen carriers. Transfusion 57:207-214, 2017.
27. Yubisui T, Takeshita M, Yoneyama Y: Reduction of methemoglobin through flavin at the physiological concentration by NADPH-flavin reductase of human erythrocytes. J Biochem (Tokyo) 87(6):1715-1720, 1980.
28. Patel MB, Feinstein AJ, Saenz AD, Majetschak M, Proctor KG: Pre-Hospital HBOC-210 after traumatic brain injury and hemorrhagic shock in swine. J Trauma 61:46-56, 2006.
29. MeledeoMA, PelteirGG, MCintosh CS, Yaylor AS, PusateriAE, CapAP. Does an HBOCaffect hemostatic functionMHSRSAbstract, Kissammee Fl, August 2017.
30. Shander A, Javidroozi M, Thompson G: Hemoglobin-based blood substitutes and risk of myocardial infarction and death (letter). JAMA 300:1296-1297, 2008.
31. Mackenzie CF, Pitman AN, Hodgson RE, Sussman MJ, Levien LJ, Jahr JS, Greenburg AG: Are hemoglobin-based oxygen carriers being withheld because of regulatory requirement for equivalence to packed red blood cells Am J Ther 22(4):e115-e121, 2015.
32. Graves PE, Henderson DP, Horstman MJ, Solomon BJ, Olson JS: Enhancing stability and expression of recombinant human hemoglobin in E. Coli: Progress in the development of a recombinant HBOC source. Biochim Biophys Acta 1784(10):1471-1479, 2008.
33. Fatalities reported to the FDA following blood collection and transfusion: Annual summary for2012. Available at: Http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/TransfusionDonationFatalities/ucm346639.htm.
34. Dutton RP, Shih D, Edelman BB, Hess J, Scalea TM: Safety of uncrossmatched type-O red cells for resuscitation from hemorrhagic shock. J Trauma 59:1445-1449, 2005.