Proof-of-concept trial to evaluate haemoglobin based oxygen therapeutics in elective percutaneous coronary revascularisation. Rationale, protocol design and haemodynamic results

EuroIntervention

Volumn 4, Issue 1, 2008, Pages 99-107

  Meliga, Emanuele ^a,d   Vranckx, Pascal ^b,c   Regar, Evelyn ^a   Kint, Peter Paul ^c   Duncker, Dirk J ^a   Serruys, Patrick W ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b Department of Cardiac Intensive Care and Interventional Cardiology ^*  (Belgium)

^c CARDIALYSIS   (Netherlands)

^d S G Battista Hospital   (Italy)

Author keywords

HBOC 201; Oxygen donor; Percutaneous coronary interventions

Indexed keywords

POLYMERIZED HEMOGLOBIN; BLOOD SUBSTITUTE; HEMOGLOBIN; OXYGEN; PLACEBO;

ADULT; AGED; ARTICLE; CARDIAC MUSCLE; CLINICAL ARTICLE; CONTROLLED STUDY; CORONARY ARTERY OCCLUSION; CROSSOVER PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ELECTROCARDIOGRAM; HEART EJECTION FRACTION; HEART LEFT VENTRICLE FUNCTION; HEART LEFT VENTRICLE PRESSURE; HEART LEFT VENTRICLE RELAXATION; HEART LEFT VENTRICLE VOLUME; HEART MUSCLE ISCHEMIA; HEART OUTPUT; HEART VENTRICLE ENDDIASTOLIC PRESSURE; HOLTER MONITORING; HUMAN; INTRACORONARY DRUG ADMINISTRATION; MALE; MUSCLE TISSUE; PERCUTANEOUS CORONARY INTERVENTION; PHASE 2 CLINICAL TRIAL; PILOT STUDY; RIGIDITY; SINGLE BLIND PROCEDURE; ST SEGMENT; TISSUE OXYGENATION; ANGINA PECTORIS; BLOOD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; ELECTROCARDIOGRAPHY; FEMALE; HEART INFARCTION; HEART STROKE VOLUME; HEART VENTRICLE PRESSURE; INFUSION PUMP; METABOLISM; MIDDLE AGED; PATHOPHYSIOLOGY; STENT; TRANSLUMINAL CORONARY ANGIOPLASTY; TREATMENT OUTCOME;

AGED; ANGINA PECTORIS; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; BLOOD SUBSTITUTES; CROSS-OVER STUDIES; ELECTROCARDIOGRAPHY, AMBULATORY; FEMALE; HEMOGLOBINS; HUMANS; INFUSION PUMPS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; OXYGEN; PILOT PROJECTS; PLACEBOS; STENTS; STROKE VOLUME; TREATMENT OUTCOME; VENTRICULAR PRESSURE;

EID: 59249103363     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/eijv4i1a17     Document Type: Article

References (30)

1. 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(1):54-64.
2. Page TC, Light WR, Hellums JD. Prediction of microcirculatory oxygen transport by erythrocyte/hemoglobin solution mixtures. Microvasc Res 1998;56(2):113-26.
3. 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 haemodilution in dogs. Can J Anaesth 1996;43(7):714-23.
4. Kasper SM, Walter M, Grune F, Bischoff A, Erasmi H, Buzello W. Effects of a hemoglobin-based oxygen carrier (HBOC-201) on hemody-namics and oxygen transport in patients undergoing preoperative hemod-ilution for elective abdominal aortic surgery. Anesth Analg 1996;83(5):921-7.
5. Matsubara T, Minatoguchi S, Matsuo H, Hayakawa K, Segawa T, Matsuno Y, Watanabe S, Arai M, Uno Y, Kawasaki M, Noda T, Takemura G, Nishigaki K, Fujiwara H. Three minute, but not one minute, ischemia and nicorandil have a preconditioning effect in patients with coronary artery disease. J Am Coll Cardiol 2000;35(2):345-51.
6. George I, Yi GH, Schulman AR, Morrow BT, Cheng Y, Gu A, Zhang G, Oz MC, Burkhoff D, Wang J. A polymerized bovine hemoglobin oxygen carrier preserves regional myocardial function and reduces infarct size after acute myocardial ischemia. Am J Physiol Heart Circ Physio 2006;291(3):H1126-37.
7. Caswell JE, Strange MB, Rimmer DM, Gibson MF, Cole P, Lefer DJ. A novel hemoglobin-based blood substitute protects against myocardial reperfusion injury. Am J Physiol Heart Circ Physiol 2005;288(4):H1796-801.
8. Burmeister MA, Rempf C, Standl TG, Rehberg S, Bartsch-Zwemke S, Krause T, Tuszynski S, Gottschalk A, Schulte am Esch J. Effects of prophylactic or therapeutic application of bovine haemoglobin HBOC-200 on ischaemia-reperfusion injury following acute coronary ligature in rats. Br J Anaesth 2005;95(6):737-45.
9. Serruys PXS, Vranckx P, Slagboom T, Regar E, Meliga E, de Winter RJ, Heyndrickx G, Schuler G, van Remortel E, Dubé GP, Symons J. Haemodynamic effects, safety, and tolerability of haemoglobin-based oxygen carrier-201 in patients undergoing PCI for CAD. EuroInterv. 2008;3:600-609
10. Braunwald E. Unstable angina: a classification. Circulation 1989;80:410-414
11. Reiber JH, Serruys PW, Kooijman CJ, Wijns W, Slager CJ, Gerbrands JJ, Schuurbiers JC, den Boer A, Hugenholtz PG. Assessment of short-, medium-, and long-term variations in arterial dimensions from computer-assisted quantitation of coronary cineangiograms. Circulation 1985;71(2):280-8.
12. Klotz S, Hay I, Dickstein ML, Yi GH, Wang J, Maurer MS, Kass DA, Burkhoff D. Single-beat estimation of end-diastolic pressure-volume relationship: a novel method with potential for noninvasive application. Am J Physiol Heart Circ Physiol 2006;291:403-412.
13. Lehman KG, Atwood E, Snyder EL. Autologous blood perfusion for myocardial protection during coronary angioplasty: a feasibility study. Circulation. 1987;76:312-323
14. Deutsch E, Berger M, Kussmaul WG, Hirshfeld JW Jr, Herrmann HC, Laskey WK. Adaptation to ischemia during percutaneous transluminal coronary angioplasty. Clinical, hemodynamic, and metabolic features. Circulation 1990;82(6):2044-51.
15. Vaitkus PT, Miller JM, Buxton AE, Josephson ME, Laskey WK. Ischemia-induced changes in human endocardial electrograms during percutaneous transluminal coronary angioplasty. Am Heart J 1994;127(6):1481-90.
16. Lim R, Laskey WK. Ischemic preconditioning in unstable coronary syndromes: evidence for time dependence. J Am Coll Cardiol 1997;30(6):1461-5.
17. Cribier A, Korsatz L, Koning R, Rath P, Gamra H, Stix G, Merchant S, Chan C, Letac B. Improved myocardial ischemic response and enhanced collateral circulation with long repetitive coronary occlusion during angioplasty: a prospective study. J Am Coll Cardiol 1992;20(3):578-86.
18. Eltchaninoff H, Cribier A, Tron C, Derumeaux G, Koning R, Hecketsweiller B, Letac B. Adaptation to myocardial ischemia during coronary angioplasty demonstrated by clinical, electrocardiographic, echocardiographic, and metabolic parameters. Am Heart J 1997 133(4):490-6
19. Airaksinen KE, Huikuri HV. Antiarrhythmic effect of repeated coronary occlusion during balloon angioplasty. J Am Coll Cardiol 1997;29(5):1035-8.
20. Billinger M, Fleisch M, Eberli FR, Garachemani A, Meier B, Seiler C. Is the development of myocardial tolerance to repeated ischemia in humans due to preconditioning or to collateral recruitment? J Am Coll Cardiol 1999;33(4):1027-35.
21. Burkhoff D, Mirsky I, Suga H. Assessment of systolic and diastolic ventricular properties via pressure-volume analysis: a guide for clinical, translational, and basic researchers. Am J Physiol Heart Circ Physiol 2005;289(2):H501-12.
22. Leite-Moreira AF, Gillebert TC. The physiology of left ventricular pressure fall. Rev Port Cardiol 2000;19(10):1015-21.
23. Bronzwaer JG, de Bruyne B, Ascoop CA, Paulus WJ. Comparative effects of pacing-induced and balloon coronary occlusion ischemia on left ventricular diastolic function in man. Circulation 1991;84(1):211-22.
24. Barry WH, Brooker JZ, Alderman EL, Harrison DC. Changes in diastolic stiffness and tone of the left ventricle during angina pectoris. Circulation 1974;49(2):255-63.
25. Serizawa T, Carabello BA, Grossman W. Effect of pacing-induced ischemia on left ventricular diastolic pressure-volume relations in dogs with coronary stenoses. Circ Res 1980;46(3):430-9.
26. Kihara Y, Grossman W, Morgan JP. Direct measurement of changes in intracellular calcium transients during hypoxia, ischemia, and reperfusion of the intact mammalian heart. Circ Res 1989; 65(4):1029-44.
27. Tian R, Nascimben L, Ingwall JS, Lorell BH. Failure to maintain a low ADP concentration impairs diastolic function in hypertrophied rat hearts. Circulation 1997;96(4):1313-9.
28. Cave AC, Inwall JS, Friedrich J, Liao R, Saupe KW, Apstein CS, and Eberli FR. ATP synthesis during low-flow ischemia: Influence of increased glycolytic substrate. Circulation 2000;101: 2090-2096.
29. Chen FC, Ogut O. Decline of contractility during ischemia-reperfusion injury: actin glutahionylation and its effect on allosteric interaction with tropomyosin. Am J Physiol Cell Physiol 20062;90:C719-C727.
30. Friedman PL, Shook TL, Kirshenbaum JM, Selwyn AP, Ganz P. Value of the intracoronary electrocardiogram to monitor myocardial ischemia during percutaneous transluminal coronary angioplasty Circulation 1986;74;330-339