Issues in the development of hemoglobin based oxygen carriers

Seminars in Hematology - Tập 56 - Trang 257-261 - 2019
Timothy N. Estep1
1Chart Biotech Consulting, Erie, CO

Tài liệu tham khảo

Friedman, 2000, Hemoglobin solutions as blood substitutes, J Invest Surg, 13, 79, 10.1080/089419300272122 Feola, 1988, Toxicity of polymerized hemoglobin solutions, Surg Gynecol Obstet, 166, 211 Reid, 2003, Hb-based oxygen carriers: are we there yet?, Transfusion, 43, 280, 10.1046/j.1537-2995.2003.00314.x Habler, 2000, Diaspirin-crosslinked hemoglobin reduces mortality of severe hemorrhagic shock in pigs with critical coronary stenosis, Crit Care Med, 28, 1889, 10.1097/00003246-200006000-00034 Rice, 2006, Bovine polymerized hemoglobin versus Hextend resuscitation in a swine model of severe controlled hemorrhagic shock with delay to definitive care, Shock, 26, 302, 10.1097/01.shk.0000226338.48033.c2 King, 2005, Resuscitation with a hemoglobin-based oxygen carrier after traumatic brain injury, J Trauma, 59, 553 Chow, 2001, Effects of diaspirin cross-linked hemoglobin (DCLHb) during and post-CPR in swine, J Pharmacol Exp Ther, 297, 224 George, 2006, A polymerized bovine hemoglobin oxygen carrier preserves regional myocardial function and reduces infarct size after acute myocardial ischemia, Am J Physiol Heart Circ Physiol, 291, H1126, 10.1152/ajpheart.00076.2006 Cole, 1993, Focal cerebral ischemia in rats: effect of hemodilution with α-α cross-linked hemoglobin on brain injury and edema, Can J Neurol Sci, 20, 30, 10.1017/S0317167100047363 Bowes, 1994, Diaspirin cross-linked hemoglobin improves neurological outcome following reversible but not irreversible CNS ischemia in rabbits, Stroke, 25, 2253, 10.1161/01.STR.25.11.2253 Horn, 1997, Bovine hemoglobin increases skeletal muscule oxygenation during 95% artificial arterial stenosis, Surgery, 121, 411, 10.1016/S0039-6060(97)90311-1 McKenzie, 1994, Effects of diaspirin crosslinked haemoglobin during coronary angioplasty in the swine, Cardiovasc Res, 28, 1188, 10.1093/cvr/28.8.1188 Crawford, 2007, The novel hemoglobin-based oxygen carrier HRC 101 improves survival in murine sickle cell disease, Anesthesiology, 107, 281, 10.1097/01.anes.0000271872.14311.b4 Teicher, 1997, PEG-hemoglobin: effects on tumor oxygenation and response to chemotherapy, In Vivo, 11, 301 Linberg, 1998, Increased tissue oxygenation and enhanced radiation sensitivity of solid tumors in rodents following polyethylene glycol conjugated bovine hemoglobin administration, In Vivo, 12, 167 Starnes, 1991, Effectiveness of a purified human hemoglobin as a blood substitute in the perfused rat liver, Gastroenterology, 101, 1345, 10.1016/0016-5085(91)90087-2 Serna, 2000, Cardiac function after eight hour storage by using polyethylene glycol hemoglobin versus crystalloid perfusion, ASAIO J, 46, 547, 10.1097/00002480-200009000-00007 Vlahakes, 1990, Hemodynamic effects and oxygen transport properties of a new blood substitute in a model of massive blood replacement, J Thorac Cardiovasc Surg, 100, 379, 10.1016/S0022-5223(19)35530-8 Gould, 1990, The efficacy of polymerized pyrodoxylated hemoglobin solution as an O2 carrier, Ann Surg, 211, 394, 10.1097/00000658-199004000-00003 Meisner, 2001, Diaspirin crosslinked hemoglobin enables extreme hemodilution beyond the critical hematocrit, Crit Care Med, 29, 829, 10.1097/00003246-200104000-00030 Schubert, 2003, Diaspirin-crosslinked hemoglobin reduces blood transfusion in noncardiac surgery: a multicenter, randomized, controlled, double-blinded trial, Anesth Analg, 97, 323, 10.1213/01.ANE.0000068888.02977.DA Jahr, 2008, 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, 10.1097/TA.0b013e318173a93f Mullon, 2000, Transfusions of polymerized bovine hemoglobin in a patient with severe autoimune hemolytic anemia, New Eng J Med, 342, 1638, 10.1056/NEJM200006013422204 Fitzgerald, 2011, A synthetic haemoglobin-based oxygen carrier and the reversal of cardiac hypoxia secondary to severe anaemia following trauma, Med J Aust, 194, 471, 10.5694/j.1326-5377.2011.tb03064.x Marrazzo, 2019, Inhaled nitric oxide prevents systemic and pulmonary vasoconstriction due to hemoglobin-based oxygen carrier infusion: a case report, J Crit Care. Epub, 51, 213, 10.1016/j.jcrc.2018.04.008 Natanson, 2008, Cell-free hemoglobin-based blood substitutes and risk of myocardial infarction and death, JAMA, 299, 2304, 10.1001/jama.299.19.jrv80007 Vostal, 2018, Proceedings of the Food and Drug Administration's public workshop on new red blood cell product regulatory science 2016, Transfusion, 58, 255, 10.1111/trf.14435 Koch, 2006, Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting, Crit Care Med, 34, 1608, 10.1097/01.CCM.0000217920.48559.D8 Obi, 2015, The association of perioperative transfusion with 30-day morbidity and mortalitiy in patients undergoing major vascular surgery, J Vasc Surg, 61, 1000, 10.1016/j.jvs.2014.10.106 Whitlock, 2015, Harms associated with single unit perioperative transfusion: retrospective population based analysis, BMJ, 350, h3037, 10.1136/bmj.h3037 Osborne, 2018, Variation in transfusion practices and the association with perioperative adverse events in patients undergoing open abdominal aortic aneurysm repair and lower extremity arterial bypass in the vascular quality initiative, Ann Vasc Surg, 46, 1, 10.1016/j.avsg.2017.06.154 Koch, 2008, Duration of red-cell storage and complications after cardiac surgery, N Engl J Med, 358, 1229, 10.1056/NEJMoa070403 Wang, 2012, Transfusion of older stored blood and risks of death: a meta-analysis, Transfusion, 52, 10.1111/j.1537-2995.2011.03466.x Baek, 2012, Hemoglobin-driven pathophysiology is an in vivo consequence of the red blood cell storage lesion that can be attenuated in guinea pigs by haptoglobin therapy, J Clin Invest, 122, 1444, 10.1172/JCI59770 Simoni, 1997, Expression of adhesion molecules and von Willebrand factor in human coronary artery endothelial cells incubated with differently modified hemoglobin solutions, Artif Cells Blood Substit Immobil Biotechnol, 25, 211, 10.3109/10731199709118911 Sloan, 1999, Diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock, JAMA, 282, 1857, 10.1001/jama.282.19.1857 Sloan, 2002, Post Hoc Mortality Analysis of the efficacy trial of diaspirin cross-linked hemoglobin in the treatment of severe traumatic hemorrhagic shock, J Trauma, 52, 887 Vane, 2002, Comparison of transfusion with DCLHb or pRBCs for treatment of intraoperative anemia in sheep, J Appl Physiol, 92, 343, 10.1152/jappl.2002.92.1.343 Fischer, 1999, Plasma volume expansion with solutions of hemoglobin, albumin, and Ringer lactate in sheep, Am J Physiol, 276, H2194 LaMuraglia, 2000, The reduction of the allogenic transfusion requirement in aortic surgery with a hemoglobin-based solution, J Vasc Surg, 31, 299, 10.1016/S0741-5214(00)90161-7 Kerner, 2003, DCH-Hb for trauma patients with severe a shock: the European “On-Scene” multicenter study, Intensive Care Med, 29, 378, 10.1007/s00134-002-1622-x Northfield laboratories releases summary observations from its elective surgery trial [news release] (2006). Evanston, IL: Northfield Laboratories Inc. Available from from http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle_print&ID=833808&highlight=. [accessed 16 December 2017]. Sloan, 2010, DCLHb Traumatic Hemorrhagic Shock Study Group; European HOST Investigators. The lack of consistent diaspirin cross-linked hemoglobin infusion blood pressure effects in the US and EU traumatic hemorrhagic shock clinical trials, Shock, 33, 123, 10.1097/SHK.0b013e3181ac482b Sloan, 2010, DCLHb Traumatic Hemorrhagic Shock Study Group; European HOST Investigators, J Trauma, 68, 1158, 10.1097/TA.0b013e3181bbfaac Moore, 2009, PolyHeme Study Group. Human polymerized hemoglobin for the treatment of hemorrhagic shock when blood is unavailable; the USA multicenter trial, J Am Coll Surg, 208, 1, 10.1016/j.jamcollsurg.2008.09.023 Estep, 2019, Haemoglobin-based oxygen carriers and myocardial infarction, Artif Cells Nanomed Biotechnol, 47, 593, 10.1080/21691401.2019.1573181 Olson, 2004, NO scavenging and the hypertensive effect of hemoglobin-based blood substitutes, Free Radic Biol Med, 36, 685, 10.1016/j.freeradbiomed.2003.11.030 Sharma, 1994, Regional circulatory and systemic hemodynamic effects of diaspirin cross-linked hemoglobin in the rat. Artif Cells, Blood Substit Immobil Biotechnol, 22, 593, 10.3109/10731199409117888 Mongan, 2009, Regional blood flow after serial normovolemic exchange transfusion with HBOC-201 (Hemopure) in anesthetized swine, J Trauma, 67, 51, 10.1097/TA.0b013e3181838030 Meliga, 2008, Proof-of-concept trial to evaluate haemoglobin based oxygen therapeutics in elective percutaneous coronary revascularization. Rationale, protocol design and haemodynamic results, EuroIntervention, 4, 99, 10.4244/EIJV4I1A17 Sakai, 2000, Molecular dimensions of Hb-based O2 carriers determine constriction of resistance arteries and hypertension, Am J Physiol Heart Circ Physiol, 279, H908, 10.1152/ajpheart.2000.279.3.H908 Biro, 2012, Adverse HBOC-endothelial dysfunction synergism: a possible contributor to adverse clinical outcomes, Curr Drug Discov Technol, 9, 194, 10.2174/157016312802650733 D'Agnillo, 2013, Redox activity of cell-free hemoglobin: implications for vascular oxidative stress and endothelial dysfunction, 665 Ma, 1997, Effect of hemoglobin- and perflubron-based oxygen carriers on common clinical laboratory tests, Clin Chem, 43, 1732, 10.1093/clinchem/43.9.1732 Björkholom, 2005, A phase I single blind clinical trial of a new oxygen transport agent (MP4), human hemoglobin modified with maleimide-activated polyethylene glycol, Haematologica, 90, 505 Cameron, 2009, Interference in clinical chemistry assays by the hemoglobin-based oxygen carrier, Hemospan. Clin Biochem., 42, 221, 10.1016/j.clinbiochem.2008.10.023 Sodi, 2006, Mechanism of interference by haemolysis in the cardiac troponin T immunoassay, Ann Clin Biochem, 43, 49, 10.1258/000456306775141687 Varlet-Marie, 2004, Detection of hemoglobin-based oxygen carriers in human serum for doping analysis: Confirmation by size-exclusion HPLC, Clin Chem, 50, 723, 10.1373/clinchem.2003.026591 ver Elst, 1999, Analytic and clinical evaluation of the Abbott AxSYM cardiac troponin I assay, Am J Clin Pathol, 112, 745, 10.1093/ajcp/112.6.745 Dasgupta, 2001, Negative interference of bilirubin and hemoglobin in the MEIA troponin I assay but not in the MEIA CK-MB assay, J Clin Lab Anal, 15, 76, 10.1002/jcla.5 Whitaker, 2016, Trends in United States blood collection and transfusion: results from the 2013 AABB blood collection, utilization, and patient blood management survey, Transfusion, 56, 2173, 10.1111/trf.13676 He, 2011, Large-scale production of functional human serum albumin from transgenic rice seeds, Proc Natl Acad Sci, 108, 19078, 10.1073/pnas.1109736108 Kim, 2012, Practical considerations in the development of hemoglobin-based oxygen therapeutics, Curr Drug Discov Technol, 9, 212, 10.2174/157016312802650779 Chang, 2013, From hemoglobin based oxygen carrier to oxygen therapeutics, blood substitutes, nanomedicine and artificial cells, 3 Kumar, 1998, Human hemoglobin derived from transgenic swine: a starting material for “blood substitute” formulations, 309 Varnado, 2013, Development of recombinant hemoglobin-based oxygen carriers, Antioxid Redox Signal, 18, 2314, 10.1089/ars.2012.4917 Weiskopf, 2013, Balancing risks and benefits of hemoglobin-based oxygen carriers, Transfusion, 53, 2327 Dubé, 2008, HBOC-201: the multi-purpose oxygen therapeutic, EuroIntervention, 4, 161, 10.4244/EIJV4I1A26 Nelson, 1993, Preparation and characterization of diaspirin cross-linked hemoglobin solutions for preclinical studies, 241 Gelderman, 2010, Serial oxygen equilibrium and kinetic measurements during RBC storage, Transfus Med, 20, 341, 10.1111/j.1365-3148.2010.01016.x Luten, 2008, Survival of red blood cells after transfusion: a comparison between red cells concentrates of different storage periods, Transfusion, 48, 1476, 10.1111/j.1537-2995.2008.01734.x