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

Anesthesia and Analgesia

Volumn 119, Issue 4, 2014, Pages 766-776

  Van Hemelrijck, Jan ^a   Levien, Lewis J ^b   Veeckman, Luc ^a   Pitman, Arkadiy ^c   Zafirelis, Zafiris ^d   Standa, Thomas ^e  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b MILPARK HOSPITAL   (South Africa)

^c Independent Biostatistics Consultant   (United States)

^d Independent Consultant   (United States)

^e UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BILIRUBIN; HEMOGLOBIN; POLYMERIZED HEMOGLOBIN; BLOOD SUBSTITUTE;

ABDOMINAL PAIN; ABSCESS; ACIDOSIS; ADULT; AGED; ANEMIA; ARTERIAL PRESSURE; ARTICLE; ASPIRATION PNEUMONIA; ASTHENIA; BILIARY TRACT PAIN; BLEEDING; BLOOD COMPONENT THERAPY; CEREBROVASCULAR ACCIDENT; COLITIS; COMPARATIVE EFFECTIVENESS; CONFUSION; CONSTIPATION; CONTROLLED STUDY; CONVALESCENCE; CONVULSION; DIARRHEA; DYSPHAGIA; DYSPNEA; EDEMA; ERYTHROCYTE; ERYTHROCYTE TRANSFUSION; EUROPE; FEMALE; FEVER; GASTROINTESTINAL SURGERY; HEART ARREST; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HEMATURIA; HOSPITAL DISCHARGE; HUMAN; HYPERTENSION; HYPOKALEMIA; HYPOTHYROIDISM; HYPOXIA; ILEUS; INFECTION; INSOMNIA; INTENSIVE CARE UNIT; INTESTINE OBSTRUCTION; JAUNDICE; LUNG DISEASE; LUNG EDEMA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; METHEMOGLOBINEMIA; MULTICENTER STUDY; NAUSEA; OBSTRUCTIVE JAUNDICE; OLIGURIA; ORTHOPEDIC SURGERY; PAIN; PATIENT SAFETY; PERITONITIS; PNEUMONIA; PNEUMOTHORAX; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RECTUM HEMORRHAGE; RESPIRATORY TRACT DISEASE; RISK ASSESSMENT; SEPSIS; SHOCK; SINGLE BLIND PROCEDURE; SOUTH AFRICA; SURGICAL PATIENT; TACHYCARDIA; URINARY TRACT INFECTION; URINE RETENTION; UROLOGIC SURGERY; VASCULAR SURGERY; VOMITING; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPARATIVE STUDY; DRUG SCREENING; FOLLOW UP; MIDDLE AGED; PERIOPERATIVE PERIOD; PROCEDURES; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; BLOOD SUBSTITUTES; DRUG EVALUATION; ERYTHROCYTE TRANSFUSION; FEMALE; FEVER; FOLLOW-UP STUDIES; HEMOGLOBINS; HUMANS; HYPERTENSION; MALE; MIDDLE AGED; PERIOPERATIVE CARE; SINGLE-BLIND METHOD; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84914157743     PISSN: 00032999     EISSN: 15267598     Source Type: Journal    
DOI: 10.1213/ANE.0000000000000305     Document Type: Article

References (34)

1. Jahr JS, Mackenzie C, Pearce LB, Pitman A, Greenburg AG. HBOC-201 as an alternative to blood transfusion: effcacy and safety evaluation in a multicenter phase III trial in elective orthopedic surgery. J Trauma 2008;64:1484-97
2. Hébert PC, Fergusson D, Blajchman MA, Wells GA, Kmetic A, Coyle D, Heddle N, Germain M, Goldman M, Toye B, Schweitzer I, vanWalraven C, Devine D, Sher GD; Leukoreduction Study Investigators. Clinical outcomes following institution of the Canadian universal leukoreduction program for red blood cell transfusions. JAMA 2003;289:1941-9
3. Vincent JL. Indications for blood transfusions: too complex to base on a single number? Ann Intern Med 2012;157:71-2
4. Deans KJ, Minneci PC, Suffredini AF, Danner RL, Hoffman WD, Ciu X, Klein HG, Schechter AN, Banks SM, Eichacker PQ, Natanson C. Randomization in clinical trials of titrated therapies: unintended consequences of using fxed treatment protocols. Crit Care Med 2007;35:1509-16
5. Carson JL, Grossman BJ, Kleinman S, Tinmouth AT, Marques MB, Fung MK, Holcomb JB, Illoh O, Kaplan LJ, Katz LM, Rao SV, Roback JD, Shander A, Tobian AA, Weinstein R, Swinton McLaughlin LG, Djulbegovic B; Clinical Transfusion Medicine Committee of the AABB. Red blood cell transfusion: a clinical practice guideline from the AABB∗. Ann Intern Med 2012;157:49-58
6. Natanson C, Kern SJ, Lurie P, Banks SM, Wolfe SM. Cell-free hemoglobin-based blood substitutes and risk of myocardial infarction and death: a meta-analysis. JAMA. 2008;299:2304-12. Epub 2008 Apr 28.
7. Erratum in: JAMA 2008;300:1300
8. Wang D, Sun J, Solomon SB, Klein HG, Natanson C. Transfusion of older stored blood and risk of death: a meta-analysis. Transfusion 2012;52:1184-95
9. Warkentin TE, Eikelboom JW. Old blood bad? Either the biggest issue in transfusion medicine or a nonevent. Transfusion 2012;52:1165-7
10. Page TC, Light WR, Hellums JD. Prediction of microcirculatory oxygen transport by erythrocyte/hemoglobin solution mixtures. Microvasc Res 1998;56:113-26
11. Page TC, Light WR, McKay CB, 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 1998;55:54-64
12. Standl T, Horn P, Wilhelm S, Greim C, Freitag M, Freitag U, Sputtek A, Jacobs E, Schulte am Esch J. Bovine haemoglobin is more potent than autologous red blood cells in restoring muscular tissue oxygenation after profound isovolaemic haemodi-lution in dogs. Can J Anaesth 1996;43:714-23
13. Freitag M, Standl TG, Gottschalk A, Burmeister MA, Rempf C, Horn EP, Strate T, Schulte Am Esch J. Enhanced central organ oxygenation after application of bovine cell-free hemoglobin HBOC-201. Can J Anaesth 2005;52:904-14
14. Muir WW, Ilangovan G, Zweier JL, Moon-Massat PF, Rentko VT. Vital organ tissue oxygenation after serial normovolemic exchange transfusion with HBOC-201 in anesthetized swine. Shock 2011;35:597-603
15. Fitzpatrick CM, Savage SA, Kerby JD, Clouse WD, Kashyap VS. Resuscitation with a blood substitute causes vasoconstriction without nitric oxide scavenging in a model of arterial hemorrhage. J Am Coll Surg 2004;199:693-701
16. Katz LM, Manning JE, McCurdy S, Pearce LB, Gawryl MS, Wang Y, Brown C; Carolina Resuscitation Research Group. HBOC-201 improves survival in a swine model of hemorrhagic shock and liver injury. Resuscitation 2002;54:77-87
17. Manning JE, Katz LM, Brownstein MR, Pearce LB, Gawryl MS, Baker CC. Bovine hemoglobin-based oxygen carrier (HBOC-201) for resuscitation of uncontrolled, exsanguinating liver injury in swine. Carolina Resuscitation Research Group. Shock 2000;13:152-9
18. McNeil CJ, Smith LD, Jenkins LD, York MG, Josephs MJ. Hypotensive resuscitation using a polymerized bovine hemoglobin-based oxygen-carrying solution (HBOC-201) leads to reversal of anaerobic metabolism. J Trauma 2001;50:1063-75
19. Philbin N, Rice J, Gurney J, McGwin G, Arnaud F, Dong F, Johnson T, Flournoy WS, Ahlers S, Pearce LB, McCarron R, Freilich D. A hemoglobin-based oxygen carrier, bovine polymerized hemoglobin (HBOC-201) versus hetastarch (HEX) in a moderate severity hemorrhagic shock swine model with delayed evacuation. Resuscitation 2005;66:367-78
20. Hughes GS Jr, Antal EJ, Locker PK, Francom SF, Adams WJ, Jacobs EE Jr. Physiology and pharmacokinetics of a novel hemoglobin-based oxygen carrier in humans. Crit Care Med 1996;24:756-64
21. Hughes GS Jr, Yancey EP, Albrecht R, Locker PK, Francom SF, Orringer EP, Antal EJ, Jacobs EE Jr. Hemoglobin-based oxygen carrier preserves submaximal exercise capacity in humans. Clin Pharmacol Ther 1995;58:434-43
22. Knebel W, Pearce LB, Gawryl M, Pentikis HS. A population analysis of data obtained in phase I-III Clinical Trials of Hemopure® (HBOC-201). Clinical Pharmacology and Therapeutics 2003;73:67
23. Serruys PW, Vranckx P, Slagboom T, Regar E, Meliga E, de Winter RJ, Heyndrickx G, Schuler G, van Remortel EA, Dubé GP, Symons J. Haemodynamic effects, safety, and tolerability of haemoglobin-based oxygen carrier-201 in patients undergoing PCI for CAD. EuroIntervention 2008;3:600-9
24. Meliga E, Vranckx P, Regar E, Kint PP, Duncker DJ, Serruys PW. Proof-of-concept trial to evaluate haemoglobin based oxygen therapeutics in elective percutaneous coronary revascularisa-tion. Rationale, protocol design and haemodynamic results. EuroIntervention 2008;4:99-107
25. Dubé GP, Vranckx P, Greenburg AG. HBOC-201: the multipurpose oxygen therapeutic. EuroIntervention 2008;4:161-5
26. Moore EE, Johnson JL, Moore FA, Moore HB. The USA Multicenter Prehosptial Hemoglobin-based Oxygen Carrier Resuscitation Trial: scientifc rationale, study design, and results. Crit Care Clin 2009;25:325-56
27. Raat NJ, Tabima DM, Specht PA, Tejero J, Champion HC, Kim-Shapiro DB, Baust J, Mik EG, Hildesheim M, Stasch JP, Becker EM, Truebel H, Gladwin MT. Direct sGC activation bypasses NO scavenging reactions of intravascular free oxy-hemoglobin and limits vasoconstriction. Antioxid Redox Signal 2013;19:2232-43
28. Kim HW, Greenburg AG. Ferrrous hemoglobin scavenging of endothelium derived nitric oxide is a principal mechanism for hemoglobin mediated vasoactivities in isolated rat thoracic aorta. Artif Cells Blood Substit Immobil Biotechnol 1997;25:121-33
29. Mongan PD, Moon-Massat PF, Rentko V, Mihok S, Dragovich A, Sharma P. Regional blood fow after serial normovolemic exchange transfusion with HBOC-201 (Hemopure) in anesthetized swine. J Trauma 2009;67:51-60
30. Te Lintel Hekkert M, Dubé GP, Regar E, de Boer M, Vranckx P, van der Giessen WJ, Serruys PW, Duncker DJ. Preoxygenated hemoglobin-based oxygen carrier HBOC-201 annihilates myocardial ischemia during brief coronary artery occlusion in pigs. Am J Physiol Heart Circ Physiol 2010;298:H1103-13
31. Carson JL, Duff A, Poses RM, Berlin JA, Spence RK, Trout R, Noveck H, Strom BL. Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Lancet 1996;348:1055-60
32. Silverman TA, Weiskopf RB. Hemoglobin-based oxygen carriers: current status and future directions. Transfusion 2009;49:2495-515
33. Silverman TA, Weiskopf RB. Hemoglobin based oxygen carriers: current status and future directions. Anesthesiology 2009;111:946-63.
34. Weiskopf RB, Silverman TA. Balancing potential risks and benefts of hemoglobin-based oxygen carriers. Transfusion 2013;53:2327-33