Crosslinked, polymerized, and peg-conjugated hemoglobin-based oxygen carriers: Clinical safety and efficacy of recent and current products

Current Drug Discovery Technologies

Volumn 9, Issue 3, 2012, Pages 158-165

  Jahr, Jonathan S ^a   Akha, Arezou Sadighi ^b   Holtby, Randall J ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

DCLHb (diaspirin crosslinked Hb) (HemAssist ); HBOC (Hemoglobin based oxygen carriers); HBOC 201 (Hemoglobin glutamer 250 bovine ; Hemoglobin raffimer (HemolinkTM); Hemopure ); Hemospan ); MP4 (malemide polyethylene glycolconjugated Hb; polymerized human Hb (PolyHeme ); zero linked hemoglobin polymer (Oxyvita )

Indexed keywords

HEMOGLOBIN; HEMOGLOBIN BASED OXYGEN CARRIER; HEMOGLOBIN GLUTAMER 256; HEMOGLOBIN RAFFIMER; MALEIMIDE POLYETHYLENE GLYCOL MODIFIED HEMOGLOBIN; MP4; OXYVITA; PLASMA SUBSTITUTE; POLYMERIZED HEMOGLOBIN; UNCLASSIFIED DRUG; ZERO LINKED HEMOGLOBIN POLYMER;

ARTICLE; BLOOD TRANSFUSION; CLINICAL EFFECTIVENESS; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG TOLERABILITY; ERYTHROCYTE TRANSFUSION; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HEART INFARCTION; HEMORRHAGIC SHOCK; HUMAN; HYPERTENSION; JAUNDICE; LEUKOCYTE COUNT; LIVER FAILURE; MEAN ARTERIAL PRESSURE; MORBIDITY; MORTALITY; OXYGEN AFFINITY; OXYGEN TRANSPORT; PANCREATITIS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SAFETY; SIDE EFFECT; SURVIVAL RATE; TISSUE OXYGENATION;

ASPIRIN; BLOOD SUBSTITUTES; CLINICAL TRIALS AS TOPIC; HEMOGLOBINS; HUMANS; MALEIMIDES; OXYGEN; POLYETHYLENE GLYCOLS;

EID: 84865444134     PISSN: 15701638     EISSN: 18756220     Source Type: Journal    
DOI: 10.2174/157016312802650742     Document Type: Article

References (56)

1. Greenburg AG, Kim HW. Review: hemoglobin-based oxygen carriers. Crit Care 2004; 8(Suppl 2): S61-S64.
2. Jahr JS, Moallempour M, Ellis JE. Transfusion update-triggers, targets, and will we ever have a blood substitute? Current Reviews in Clinical Anesthesia 2008; 28(21): 249-60.
3. Jahr JS, Sadighi Akha A, Doherty L, Li A, Kim HW. Chapter 22: Hemoglobin-based Oxygen Carriers: History, Limits, Brief Sum-mary of the State of the Art, Including Clinical Trials. In: Chemis-try and Biochemistry of Oxygen Therapeutics: from Transfusion to Artificial Blood, First Edition. Edited by Andrea Mozzarelli and Stefano Bettati. John Wiley and Sons Ltd, London, England 2011; 301-16.
4. Amberson W. Blood Substitutes. Biological Reviews 1937; 12: 48-86.
5. Winslow RM. Alpha alpha-crosslinked hemoglobin: was failure predicted by preclinical testing? Vox Sang 2000; 79: 1-20.
6. Sloan EP, Koenigsberg M, Gens D, et al. Diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemor-rhagic shock: a randomized controlled efficacy trial. JAMA 1999; 282(19): 1857-64.
7. Cheng DC, Mazer CD, Martineau R, et al. A phase II dose-response study of Hemoglobin Raffimer (Hemolink) in elective coronary artery bypass surgery. J Thorac Cardiovasc Surg 2004; 127: 79-86.
8. Jahr JS, Moallempour M, Lim JC. HBOC-201, Hemoglobin Glu-tamer 250 (Bovine), Hemopure® (Biopure Corporation, Cambridge, MA). Expert Opin Biol Ther 2008; 8(9): 1425-33.
9. Jahr JS, Varma N. Poly Heme. IDrugs 2004; 7(5): 478-82.
10. (a) Natanson C, Kern SJ, Lurie P, Banks SM, Wolfe SM. Cell-free hemoglobin-based blood substitutes and risk of myocardial infarc-tion and death. JAMA 2008; 299: 2304-12.
11. Fergusson DA, Mc Intyre L. Editorial: the future of clinical trials evaluating blood substitutes. JAMA 2008; 299(19): 2324-6.
12. Levien LJ, Hodgson RE, James M.F.M. Hemoglobin-based blood substitutes and risk of myocardial infarction and death. JAMA 2008; 300(11): 1295.
13. Keipert PE, Olofsson C, Winslow RM. Letters: hemoglobin-based blood substitutes and risk of myocardial infarction and death. JAMA 2008; 300(11): 1295-6.
14. Lewis RJ, Fost N. Letters: hemoglobin-based blood substitutes and risk of myocardial infarction and death. JAMA 2008; 300(11): 1296.
15. Shander A, Javidroozi M, Thompson G. Letters: hemoglobin-based blood substitutes and risk of myocardial infarction and death. JAMA 2008; 300(11): 1296-7.
16. Sauaia A, Moore EE, Banerjee A. Letters: hemoglobin-based blood substitutes and risk of myocardial infarction and death. JAMA 2008; 300(11): 1297.
17. (h) Sarani B, Gracias V. Letters: hemoglobin-based blood substi-tutes and risk of myocardial infarction and death. JAMA 2008; 300(11): 1297-8.
18. (i) Natanson C, Lurie P, Wolfe SM. Letters: hemoglobin-based blood substitutes and risk of myocardial infarction and death-reply. JAMA 2008; 300(11): 1298-9.
19. (j) Fergusson D, Mc Intyre L. Letters: hemoglobin-based blood substitutes and risk of myocardial infarction and death-reply. JAMA 2008; 300(11): 1299.
20. (k) Natanson C. Letters: incomplete financial disclosure in a study of cell-free hemoglobin-based blood substitutes and risks of myo-cardial infarction and death. JAMA 2008; 300(11): 1300.
21. Silverman TA, Weiskopf RB. Hemoglobin-based oxygen carriers: current status and future directions. Anesthesiology 2009; 111: 946-63.
22. Crawford MW, Shichor T, Engelhardt T, et al. The novel hemoglo-bin-based oxygen carrier HRC 101 improves survival in murine sickle cell disease. Anesthesiology 2007; 107: 281-7.
23. Jahr JS. Editorial: Do approved blood substitutes reduce myocar-dial infarction size: is this the critical question? Br J Anaesth 2009; 103: 470-1.
24. Jahr JS. Editorial: Are newer generation hemoglobin-based oxygen carriers safe: do they offer an answer? Vascul Pharmacol 2010; 52: 214.
25. Gould SA, Moore EE, Hoyt DB, et al. The life-sustaining capacity of human polymerized hemoglobin when red cells might be un-available. JACS 2002; 195: 445-55.
26. Gould SA, Moss GS. Clinical development of human polymerized hemoglobin as a blood substitute. World J Surg 1996; 20: 1200-7.
27. Lamy ML, Daily EK, Brichant JF, et al. Randomized trial of dias-pirin cross-linked hemoglobin solution as an alternative to blood transfusion after cardiac surgery. Anesthesiology 2000; 92: 646-56.
28. Reah G, Bodenham AR, Mallick A, Daily EK, Przybelski RJ. Ini-tial evaluation of diaspirin cross-linked hemoglobin as a vasopres-sor in clinically ill patients. Crit Care Med 1997; 25: 1480-8.
29. Savitsky JP, Docze J, Black J, Arnold JD. A clinical trial of stroma-free hemoglobin. Clin Pharmacol Ther 1978; 23: 73-80.
30. Moore EE, Moore FA, Fabian TC, et al. Human polymerized he-moglobin for the treatment of hemorrhagic shock when blood is unavailable: the USA multicenter trial. JACS 2009; 208: 1-13.
31. OPK Biotech. Hemopure. http://opkbiotech.com/hemopure/hem-opure-why.php (Accessed November 30, 2010).
32. Dube GP, Vranckx P, Greenburg AG. HBOC-201: the multi-purpose oxygen therapeutic. Eurointervention 2008; 4: 161-5.
33. Levy JH, Goodnough LT, Greilich PE, et al. Polymerized bovine hemoglobin solution as a replacement for allogeneic red blood cell transfusion after cardiac surgery: results of a randomized, double-blind trial. J Thorac Cardiovasc Surg 2002; 124(1): 35-42.
34. La Muraglia GM, O'Hara P, Baker WH, et al. The reduction of the allogeneic transfusion requirement in aortic surgery with a hemo-globin-based solution. J Vasc Surg 2000; 31: 299-308.
35. 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 orthope-dic surgery. J Trauma 2008; 64: 1484-97.
36. Olofsson C, Nygards EB, Ponzer S, et al. A randomized, single blind, increasing dose safety trial of an oxygen-carrying plasma ex-pander (Hemospan) administered to orthopedic surgery patients with spinal anesthesia. Transfus Med 2008; 18: 28-39.
37. Tsai A, Vandegriff K, Intaglietta M, Winslow R. Targeted O2 delivery by cell free hemoglobin: a new basis for O2 therapeutics. Am J Physiol 2003; 285: H1411-9.
38. Young M, Riddez L, Kjellstrom B, et al. Mal PEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival af-ter uncontrolled hemorrhage in anesthetized swine. Crit Care Med 2005; 33: 1794-804.
39. Bjorkholm M, Fagrell B, Przybelski R, Winslow N, Young M, Winslow R. A phase I single blind clinical trial of a new oxygen transport agent (MP4), human hemoglobin modified with maleimide-activated polyethylene glycol. Haematologica 2005; 90: 505-15.
40. Zarin J, Grosvenor D, Schurman D, Goodman S. Efficacy of in-traoperative blood collection and reinfusion in revision total hip ar-throplasty. J Bone Joint Surg Am 2003; 85-A: 2147-51.
41. Olofsson C, Ahl T, Johansson T, et al. A multicenter clinical study of the safety and activity of Maleimide-Polyethylene Glycol-modified Hemoglobin (Hemospan) in patients undergoing major orthopedic surgery. Anesthesiology 2006; 105: 1153-63.
42. Razynska A, Bucci E. Zero-Linked polymerization: a new class of polymeric hemoglobins. Elsevier Science 1998; 21: 265-279.
43. Harrington JP, Wollocko J, Kostecki E, Wollocko H. Physiochemi-cal characteristics of Oxy Vita Hemoglobin, a zero-linked polymer: liquid and powder preparations. Artif Cells Blood Substit Immobil Biotechnol 2010; 39: 12-8.
44. Matheson B, Kwansa HE, Bucci E, Rebel A, Koehler RC. Vascular response to infusions of nonextravasating hemoglobin polymer. J Appl Physiol 2002; 93: 1479-86.
45. Cabrales P, Sun G, Zhou Y, et al. Effects of molecular mass of tense-state polymerized bovine hemoglobin on blood pressure and vasoconstriction. J Appl Physiol 2009; 107: 1548-58.
46. Reynolds PS, Barbee RW, Skaflen MD, Ward KR. Low-volume resuscitation cocktail extends survival after severe hemorrhagic shock. Shock 2007; 28: 45-52.
47. Rebel A, Ulatowski JA, Kwansa H, Bucci E, Koehler RC. Cere-brovascular response to decreased hematocrit effect of cell-free hemoglobin, plasma viscosity, and CO2. Am J Physiol Heart Circ Physiol 2003; 285: H650-H659.
48. Sampei K, Ulatowski JA, Asano Y, Kwansa H, Bucci E, Koehler RC. Role of nitric oxide scavenging in vascular response to cell-free hemoglobin transfusion. Am J Physiol Heart Circ Physiol 2005; 289: H1191-H1201.
49. Mito T, Nemoto M, Kwansa H, et al. Decreased damage from transient focal cerebral ischemia by transfusion of zero-link hemo-globin polymers in mouse. Stroke 2009; 40: 278-84.
50. Mc Carthy MR, Vandergriff KD, Winslow RM. The role of facili-tated diffusion in oxygen transport by cell-free hemoglobins: impli-cations for the design of hemoglobin-based oxygen carriers. Biophys Chem 2001; 92; 103-10.
51. Vandergriff KD. The role of oxygen and hemoglobin diffusion in oxygen transport by cell-free hemoglobin. Chapter 5. In: Winslow RM, Ed. Blood Substitutes. Elsivier, Inc. London, 2006: 60-71.
52. Harrington JP, Wollocko H. Pre-clinical studies using Oxy Vita hemoglobin, a zero-linked polymeric hemoglobin: a review. J Artif Organs 2010; 13: 183-8.
53. Jahr JS, Weeks DL, Desai P, et al. Does Oxy Vita, a new-generation hemoglobin-based oxygen carrier, or Oxyglobin acutely interfere with coagulation compared with normal saline or 6% hetastarch? J Cardiothorac Vasc Anesth 2008; 22: 34-8.
54. Kim HW, Hai CM, Greenburg AG. Acellular hemoglobin-based oxygen carrier induced vasoactivity: a brief review of potential pharmacologic remedies. Artificial Blood 2009; 17: 147-59.
55. Jahr JS, Walker V, Manoochehri K. Blood Substitutes as pharma-cotherapies in clinical practice. Curr Opin in Anaesthesiol 2007; 20: 325-30.
56. Kim HW, Greenburg AG. Artificial oxygen carriers as red blood cell substitutes: a selected review and current status. Artificial Organs 2004; 28: 613-828.