Blood substitutes- the polyheme trials

McGill Journal of Medicine

Volumn 11, Issue 1, 2008, Pages 59-65

  Apte, Sameer S ^a  

^a MCGILL UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARTIFICIAL BLOOD; HEMOGLOBIN; POLYMERIZED HEMOGLOBIN;

BLEEDING; BLOOD SUBSTITUTION; BLOOD TRANSFUSION; CLINICAL TRIAL; ERYTHROCYTE; HEMORRHAGIC SHOCK; HUMAN; OXYGEN SATURATION; REVIEW; TRAFFIC ACCIDENT;

EID: 41149086655     PISSN: 1201026X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (62)

1. Dickert, N.W. and J. Sugarman, Getting the ethics right regarding research in the emergency setting: lessons from the PolyHeme study. Kennedy Inst Ethics J, 2007. 17(2): p. 153-69.
2. Comm-Health, 21CFR50.24 - Informed Consent of Human Subjects, FDA, Editor. 1996, Health and Human Resources.
3. Biros, M.H., Research without Consent: Exceptin from and Waiver of Informed Consent in Resuscitation Research. Sci Eng Ethics, 2007. Epub ahead of Print.
4. Ellis, G.B. and M.H. Lin. (45CFR Part 46) OPRR Reports: Informed Consent Requirements in Emergency Research. 1996 (cited 97-01; Available from: http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc97-01.htm.
5. Northfield-Laboratories. Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting. 2004 July 31st 2006 (cited 2008 January 15th); Available from: http://clinicaltrials.gov/ct2/show/NCT00076648.
6. Dougherty, A.H., Letter to the Editor: In Defense of the PolyHeme Trial. Am J Bioeth, 2006. 6(5): p. W35.
7. Holloway, K.F.C., Accidental Communities: Race, Emergency Medicine, and The Problem of PolyHeme. Am J Bioeth, 2006. 6(3): p. 1-11.
8. Holloway, K.F.C., Response to Open Peer Commentaries on "Accidental Communities: Race, Emergency Medicine, and the Problem of PolyHeme": The "R" Word: Bioethics and a (Dis)Regard of Race. Am J Bioeth, 2006. 6(3): p. W46-W48.
9. Kipnis, K., N.M.P. King, and R.M. Nelson, Response to Open Peer Commentaries on "An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme® Trial": The Emergency Exception and Unproven/Unsatisfactory Treatment. Am J Bioeth, 2006. 6(3): p. W49-W50.
10. Kipnis, K., N.M.P. King, and R.M. Nelson, Trials and Errors: Barriers to Oversight of Research Conducted Under the Emergency Research Consent Waiver. IRB - The Hastings Center, 2006. 28(2): p. 16-19.
11. Kipnis, K., N.M.P. King, and R.M. Nelson, An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme® Trial. Am J Bioeth, 2006. 6(3): p. 18-21.
12. McKenna, M., Polyheme and the Ethics of Informed Consent. Ann Emerg Med, 2006. 48(5): p. 563-566.
13. Shamoo, A.E., Letter to the Editor: Emergency Research Consent Waiver - A Proper Way. Am J Bioeth, 2006. 6(4): p. W48.
14. Molter, N.C., Exemption of informed consent (final rule): procedures for critical trauma studies. J Trauma, 2007. 62(6 Suppl): p. S78-9.
15. Longfield, J.N., et al., Community meetings for emergency research community consultation*. Crit Care Med, 2007.
16. Moore, K.M., Controversies in Fluid Resuscitation. J Trauma Nurs, 2006. 13(4): p. 168-172.
17. Landsteiner, Karl Landsteiner - Biography. Nobel Lectures - Physiology or Medicine 1922-1941. 1965, Amsterdam: Elsevier Publishing Company.
18. Spiess, B.D., Choose one: Damned if you do/damned if you don't! Crit Care Med, 2005. 33(8): p. 1871-1874.
19. Sullivan, M.T., et al., Blood collection and transfusion in the United States in 2001. Transfusion, 2007. 47: p. 385-394.
20. Spiess, B.D., Risks of Transfusions: Outcome Focus. Transfusion, 2004. 4: p. 4S-14S.
21. Sazama, K., The Ethics of Blood Management. Vox Sanguinis, 2007. 92: p. 95-102.
22. Cable, R., et al., Practice Guidelines for Blood Transfusion: A Compilation from Recent Peer Reviewed Literature. 2002, Washington: American National Red Cross.
23. Zou, S., et al., Changing age distribution of the blood donor population in the United States. Transfusion, 2007.
24. Spiess, B.D., The Body, in Discovery 2057. 2007, Discovery Channel, Inc.: United States. p. 60min.
25. Kim, H.W. and A.G. Greenburg, Toward 21st Century Blood Component Replacement Therapeutics: Artificial Oxygen Carriers, Platelet Substitutes, Recombinant Clotting Factors, and Others. Art Cells Blood Subs Immob Biotech, 2006. 34: p. 537-550.
26. Mosa, M.M. and D.C.H. Cheng, Oxygen Therapeutics (Blood Substitutes) in Cardiac Surgery. Curr Opin Anaesthesiol, 2003. 16: p. 21-26.
27. Winslow, R.M., Current status of oxygen carriers ('blood substitutes'). Vox Sanguinis, 2006. 91: p. 102-110.
28. Chang, T.M.S., Blood Substitutes: Principles, Methods, Products and Clinical Trials. Vol. I. 1997, Basel: Karger Landes Systems.
29. Chang, T.M.S., Blood substitutes based on nanobiotechnology. Trends in Biotechnology, 2006. 24(8): p. 372-377.
30. Feit, A. and R.N. Sladen, New Haemoglobin Substitutes. Curr Opin Anaesthesiol, 1999. 12(4): p. 473-479.
31. Gould, S.A., et al., The First Randomized Trial of Human Polymerized Hemoglobin as a Blood Substitute in Acute Trauma and Emergent Surgery. J Am Coll Surg, 1998. 187(2): p. 113-120.
32. Habib, F.A. and S.M. Cohn, Blood substitutes. Curr Opin Anaesthesiol, 2004. 17: p. 139-143.
33. Stollings, J.L. and L.J. Oyen, Oxygen Therapeutics: Oxygen Delivery Without Blood. Pharmacotherapy, 2006. 26(10): p. 1453-1464.
34. Gould, S.A., et al., The Life-Sustaining Capacity of Human Polymerized Hemoglobin when Red Cells Might Be Unavailable. J Am Coll Surg, 2002. 195(4): p. 445-452.
35. Petricciani, J.C. and J.S. Epstein, The Effect of the AIDS Epidemic on the Safety of the Nation's Blood Supply. Pub Health Reports, 1988. 103(3): p. 236-241.
36. Madjdpour, C., V. Heindl, and D.R. Spahn, Risks, Benefits, Alternatives and Indications of Allogeneic Blood Transfusions. Minerva Anestesiol, 2006. 72: p. 283-298.
37. Moore, E.E., et al., Hemoglobin-Based Oxygen Carriers in Trauma Care: Scientific Rationale for the US Multicenter Prehosptial Trial. World J Surg, 2006. 30: p. 1247-1257.
38. Spahn, D.R. and D. Pasch, Physiological Properties of Blood Substitutes. News Physiol Sci, 2001. 16: p. 38-41.
39. Riess, J.G., Perfluorocarbon-based Oxygen Delivery. Art Cells Blood Subs Immob Biotech, 2006. 34: p. 567-580.
40. Rogers, D.M. and K.P. Crookston, The approach to the patient who refuses blood transfusion. Transfusion, 2006. 46: p. 1471-1477.
41. Smith, S.E., et al., The administration of polymerized human hemoglobin (Pyridoxylated) to a Jehovah's Witness after submyeloablative stem cell transplantation complicated by delayed graft failure. Compr Ther, 2006. 32(3): p. 172-5.
42. Tsuchida, E., et al., Hemoglobin Vessicles as a Transfusion Alternative. Art Cells Blood Subs Immob Biotech, 2006. 34: p. 581-588.
43. Fleming, P., Perceptions in Transfusion Medicine: A Pilot Field Study on Risk and Ethics for Blood and Blood Substitutes. Art Cells Blood Subs Immob Biotech, 2007. 35: p. 149-156.
44. Picard, A., The Red Blood Cell Man. McGill News, 1996. 76(4): p. 22-25.
45. Riess, J.G., Understanding the Fundamentals of Perfluorocarbons and Perfluorocarbon Emulsions Relevant to In Vivo Oxygen Delivery. Art Cells Blood Subs Immob Biotech, 2005. 33: p. 47-63.
46. Jahr, J.S., V. Walker, and K. Manoochehri, Blood substitutes as pharmacotherapies in clinical practice. Curr Opin Anaesthesiol, 2007. 20(4): p. 325-30.
47. Olofsson, C., 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(6): p. 1153-63.
48. Doherty, D.H., et al., Rate of Reaction with Nitric Oxide Determines the Hypertensive Effect of Cell-Free Hemoglobin. Nature Biotech, 1998. 16: p. 672-676.
49. Schubert, A., et al., Diaspirin-Crosslinked Hemoglobin Reduces Blood Transfusion in Noncardiac Surgery: A Multicenter, Randomized, Controlled, Double-Blinded Trial. Anesth Analg, 2003. 97: p. 323-332.
50. Yu, B., Z. Liu, and T.M.S. Chang, Polyhemoglobin with Different Percentage of Tetrameric Hemoglobin and Effects on Vasoactivity and Electrocardiogram. Art Cells Blood Subs Immob Biotech, 2006. 34: p. 159-173.
51. Kim, H.W. and A.G. Greenburg, Artificial Oxygen Carriers as Red Blood Cell Substitutes: A Selected Review and Current Status. Art Organs, 2004. 28(9): p. 813-828.
52. Anonymous. Special Protocol Assessment, Guidance. 2002 [cited; Available from: http://www.fda.gov/cder/guidance/3764fnl.pdf.
53. Congress, U.S., Modernization Act, U.H.o.R.a.U. Senate, Editor. 1997.
54. Hallstrom, A.P., J.P. Ornato, and M. Weisfeldt, Public Access Defibrillation Trial Investigators. Public-access defibrillation and survival after out-of-hospital cardiac arrest. . NEJM, 2004. 351(7): p. 637-646.
55. Anonymous, Human haemoglobin - Northfield. BioDrugs, 2003. 17(4): p. 296-8.
56. Gould, S.A., et al., Clinical experience with human polymerized hemoglobin. Transfusion, 1993. 33: p. 60S.
57. Gould, S.A. Results of Pivotal Phase III Clinical Trial. 2007 May 23rd [cited January 16th 2007); Available from: http://phx.corporate-ir.net/phoenix. zhtml?c=91374&p=irol-newsArticle&ID=1005951&highlight=.
58. Gould, S.A., et al., Clinical Utility of Human Polymerized Hemoglobin as a Blood Substitute after Acute Trauma and Urgent Surgery. Trauma Injury Infection Crit Care, 1997. 43(2): p. 325-332.
59. Salzman, J.G., et al., Implementing emergency research requiring exception from informed consent, community consultation, and public disclosure. Ann Emerg Med, 2007. 50(4): p. 448-55, 455 e1-4.
60. Lewis, R.J. and N. Fost, Monitoring a Clinical Trial With Waiver of Informed Consent: Diaspirin Cross-Linked Hemoglobin for Emergency Treatment of Post-Traumatic Shock, in Data Monitoring in Clinical Trials. 2006, Springer New York: New York.
61. Fulda, G. Polyheme Trauma Trial - Community Consultation. [Powerpoint presentation] 2006 May 15th [cited; 1-6]. Available from: http://www.fda.gov/ ohrms/dockets/dockets/95s0158/95s-0158-sup0037-02-Christiana-Care-HS-vol41.pdf.
62. Mann, H., Clinical Trial Protocols: Agreements Between the FDA and Industrial Sponsors. The Lancet, 2002. 360: p. 1345-1346.