Haviland Enviro Corp V.HEC

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Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery This study is currently recruiting patients. Sponsored by Hemosol Purpose To evaluate the efficacy of Hemolink™ in combination with Intraoperative Autologous Donation (IAD) versus control (IAD alone) in facilitating avoidance of allogeneic RBC transfusion during and following primary CABG surgery Condition Treatment or Intervention Phase Cardiovascular Disease Drug: Hemolink (hemoglobin raffimer IV solution) Phase II Phase III MEDLINEplus related topics: Circulatory Disorders; Heart Diseases (General) Study Type: Interventional Study Design: Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study Official Title: A Phase II, Randomized, Single-Blind, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Hemolink[tm] (o-raffinose cross-linked human hemoglobin) in Subjects Undergoing Primary Coronary Artery Bypass Grafting Surgery Further Study Details: All subjects who consent to take part in the protocol and who meet the inclusion/exclusion criteria will undergo the IAD harvest following a post-induction IAD harvest calculation. IAD blood will be collected into citrate-phosphate-dextrose-adenine 1 (CPDA-1) blood bags. All subjects will receive a volume of Hespan® equal to the volume of their IAD harvest (to a maximum of 1 liter) performed as a result of the harvest calculation (0–1200 mL inclusive). Additional volume replacement required owing to IAD >1000mL will be performed with crystalloid, as required. Subjects will be randomized into one of two treatment arms (Hemolink™ arm or control arm) upon meeting a transfusion trigger for the first time while on CPB. Randomization will be administered centrally. Subjects will be transfused upon reaching predetermined transfusion triggers, reflecting a decrease in hemoglobin concentration and/or oxygenation: Eligibility Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both Criteria Inclusion Criteria: Subjects meeting all of the following criteria are eligible for inclusion in the study: Written Informed Consent. Age 18 through 80 years, inclusive. Scheduled for primary CABG surgery with CPB and are candidates for IAD. Post-induction hemoglobin, which will allow collection of 0-1200 mL inclusive of IAD blood to achieve a target hemoglobin of 7.5 g/dL at 15 minutes on-CPB. For women of childbearing potential only, able to use and using a highly-effective contraceptive method from the time of study screening through week 4 - 8 post CABG surgery (follow-up visit). Note: International Conference on Harmonization (ICH) guidelines define a highly-effective contraceptive method as one with a failure rate of less than one percent when used consistently and correctly Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: Previous treatment with Hemolink(tm) or any other hemoglobin-based oxygen carrier. Participation in any clinical trial of an investigational drug, device, or medical procedure within the two months prior to enrollment, or concurrent with participation in this study. History of stroke with residual paralysis or of transient ischemic attacks within 6 months prior to surgery. Congenital coagulation disorder or treatment with Coumadin within seven days prior to surgery. Alcohol or drug use within the 12 months prior to enrollment, which the investigator considers abusive. Planned simultaneous surgery (e.g., valve repair or carotid endarterectomy). Emergency CABG. Previous surgery using sternotomy. Current pregnancy or nursing. Chronic pancreatitis with or without pancreatic insufficiency. Any subject who is medically cleared for both the surgical procedure and the intraoperative autologous donation will be eligible for enrollment in the study. Medical clearance requires the following: No current congestive heart failure, New York Heart Association class IV. Most recent (within 1 year of surgery) ejection fraction must not be less than or equal to 25 percent, or left ventricular function of grade 4. No current uncontrolled hypertension. No current severe pulmonary disease which will render the subject at high risk of requiring prolonged post-operative ventilation. No serum creatinine > 2.0 mg/dL (177 umol/L). No known AST and ALT and bilirubin > 3 times the upper limit of normal. No uncontrolled angina within 24 hours prior to surgery despite maximal medical treatment, and/or presence of an intraaortic balloon pump preoperatively. No history of transmural myocardial infarction within the five days prior to the scheduled CABG surgery. Expected Total Enrollment: 180 Location and Contact Information California Stanford University Medical Center: Department of Anesthesiology, Stanford, California, 94305, United States; Recruiting Angela Mignea 650-725-0376 [e-mail] Christina Mora Mangano, Principal Investigator Kaiser Permanente Medical Center - San Francisco-Division of Cardiovascular Anesthesia, San Francisco, California, 94115, United States; Recruiting Amy Mueller 415-833-3468 [e-mail] Gary Roach, Principal Investigator Pomona Valley Hospital Medical Center, Pomona, California, 91767, United States; Recruiting Joyce Stockwell 909-628-8828 [e-mail] Rohit Trivedi, Principal Investigator Florida Clinical Research Center, Sarasota, Florida, 34239, United States; Recruiting Janae Bell 941-917-1211 [e-mail] Clifton Lewis, Principal Investigator Morton Plant Mease Health Care, Clearwater Beach, Florida, 33756, United States; Recruiting Teresa Jones 727-461-8876 [e-mail] Richard Murbach, Principal Investigator Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States; Recruiting Charlotte Richmond 305-674-2199 [e-mail] Gervasio Lamas, MD, Principal Investigator Georgia St. Joseph's Health System, Atlanta, Georgia, 30342, United States; Recruiting Sonya Mathewson 404-252-8377 [e-mail] Stanley Mogelnicki, Principal Investigator Indiana CorVasc, Indianapolis, Indiana, 46260, United States; Recruiting Linda Cutcliff 317-338-9255 [e-mail] Keith Allen, Principal Investigator Iowa Heart and Vascular Care, Des Moines, Iowa, 50314, United States; Recruiting Pam Normandin 515-241-6056 Ronald Grooters, Principal Investigator Iowa Heart Center, Des Moines, Iowa, 50314, United States; Recruiting Teresa Coulson 515-235-5100 [e-mail] Robert Zeff, Dr., Principal Investigator Maryland Sinai Hospital of Baltimore, Baltimore, Maryland, 21215, United States; Recruiting Erin Griffeth 410-601-8779 [e-mail] Peter Cho, Principal Investigator St. Joseph's Hospital, Towson, Maryland, 21201, United States; Recruiting Kristin Schomer 410-427-2326 [e-mail] Robert Horneffer, Principal Investigator Michigan Henry Ford Hospital, Detroit, Michigan, 48202, United States; Recruiting Trish Currie 313-916-8006 [e-mail] Robert Brewer, MD, Principal Investigator Missouri Washington University, St. Louis, Missouri, 63110, United States; Recruiting Heidi Hahn 314-747-4405 [e-mail] Eric Jacobsohn, Principal Investigator New Jersey Robert Wood Johnson Hospital, New Brunswick, New Jersey, 08901, United States; Recruiting Kim Cocozello 732-235-6287 [e-mail] Alann Solina, Principal Investigator Englewood Hospital, Englewood, New Jersey, 07361, United States; Recruiting Henry L Bennett 201-894-3916 [e-mail] Aryeh Shander, MD, Principal Investigator New York Mount Sinai Medical Center, New York, New York, 10029-6574, United States; Recruiting Donna Harrington 212-241-7467 [e-mail] Linda Shore-Lesserson, Principal Investigator North Carolina Duke University Medical Center, Durham, North Carolina, 27710, United States; Recruiting Vince Gaver 919-681-4729 [e-mail] Stephen Hill, Principal Investigator University of North Carolina: Department of Anesthesiology, Chapel Hill, North Carolina, 27514, United States; Recruiting Tammi Jaynes 919-966-7505 [e-mail] Warner Lucas, Principal Investigator Ohio The Ohio State University Department of Anesthesiology, Columbus, Ohio, 43210, United States; Recruiting Sharon Parker 614-293-8487 [e-mail] Michael Howie, MD, Principal Investigator Oregon Veterans Affairs Medical Center, Portland, Oregon, 97201, United States; Recruiting Prudence Marshall 503-220-8262 Ext. 57583 [e-mail] Grace Chien, Principal Investigator Legacy Research, Portland, Oregon, 97232, United States; Recruiting Susan Duman 503-413-1930 [e-mail] John Lemmer, Principal Investigator Pennsylvania UPMC Health System, Pittsburgh, Pennsylvania, 15213, United States; Recruiting Susan Tamburro 412-692-2854 [e-mail] Erin Sullivan, Principal Investigator Texas Cardiovascular Anesthesia Research:Texas Heart Institute, Houston, Texas, 77225-0345, United States; Recruiting Juliette Dean 832-355-3265 [e-mail] Nancy Nussmeier, Principal Investigator Baylor College of Medicine, Houston, Texas, 77030, United States; Recruiting Raquel Reyna 713-798-8566 [e-mail] Luis Velez-Pestana, Principal Investigator Virginia Inova Fairfax Hospital, Falls Church, Virginia, 55042-3300, United States; Recruiting Pamela Stenborg 703-698-2326 [e-mail] Robert Albus, Principal Investigator Sentara Norfolk General Hospital, Norfolk, Virginia, 23507, United States; Recruiting Jennine Zumbuhi 757-668-4193 [e-mail] Robert Hagberg, Principal Investigator Medical College of Virginia: Department of Anesthesiology, Richmond, Virginia, 23298-0695, United States; Recruiting Kelli Makhoul 804-828-9160 Ext. 236 [e-mail] Bruce Speiss, Principal Investigator McGuire VA Medical Center, Richmond, Virginia, 23249, United States; Recruiting Alice Bartholomew 804-675-5465 [e-mail] Lauraine Stewart, Principal Investigator West Virginia CAMC Health Education and Research Institute, Charleston, West Virginia, 25304, United States; Recruiting Jean Matthews 604-388-9935 Sulaiman Bashir Hasan, Principal Investigator Canada, Alberta Foothills Medical Centre, Calgary, Alberta, T2N 2T9, Canada; Recruiting Karen Maier 403-944-4713 [e-mail] Charles MacAdams, MD, Principal Investigator Canada, British Columbia St. Paul's Hospital/ Vancouver General Hospital, Vancouver, British Columbia, VZ 4E3, Canada; Recruiting Stephanie Taylor 604-682-2344 Ext. 62103 [e-mail] Brian Warriner, Dr., Principal Investigator Canada, Ontario St. Michael's Hospital, Toronto, Ontario, M5B 1W8, Canada; Recruiting Jorge Cruz 416-864-5825 [e-mail] David Mazer, MD, Principal Investigator The Toronto Hospital - General Division, Toronto, Ontario, M5G 2C4, Canada; Recruiting Jo Carroll 416-340-4800 Ext. 3243 [e-mail] Jacob Karski, MD, Principal Investigator Kingston General Hospital, Kingston, Ontario, K7L 2V7, Canada; Recruiting Beth Orr 613-549-6666 Ext. 3224 [e-mail] John Cain, MD, Principal Investigator Canada, Quebec Hopital Laval, Ste Foy, Quebec, G1V 4G5, Canada; Recruiting Julie Soucy 418-656-8711 Ext. 2660 [e-mail] Lucie Auclair 418-656-8711 Ext. 2702 [e-mail] Dany Cote, MD, Principal Investigator Institut de Cardiologie de Montreal, Montreal, Quebec, H1T 1C8, Canada; Recruiting Micheline Roy 514-376-3330 Ext. 3732 [e-mail] Raymond Martineau, Principal Investigator United Kingdom, England The Cardiothoracic Centre, Liverpool, England, L14 3PE, United Kingdom; Recruiting Heather Rogers 1512-932-345 [e-mail] Mike Desmond, Principal Investigator Southampton General Hospital, Southampton, England, SO16 6YD, United Kingdom; Recruiting Kim Golder 2380-794-216 [e-mail] Ravi Gill, Principal Investigator St. Thomas Hospital: Department of Anesthesia, London, England, SE1 7EH, United Kingdom; Recruiting Corina Naughton 2079-289-292 Ext. 2353 Rob Feneck, Principal Investigator United Kingdom, London Papworth Hospital: Department of Anesthesia, Cambridge, London, CB38RE, United Kingdom; Recruiting Helen Munday 1480-364-406 [e-mail] Alain Vuylsteke, Principal Investigator More Information Publications Jahr JS, Lurie F, Driessen B, Davis JA, Gosselin R, Gunther RA. The HemoCue, a point of care B-hemoglobin photometer, measures hemoglobin concentrations accurately when mixed in vitro with canine plasma and three hemoglobin-based oxygen carriers (HBOC). Can J Anaesth. 2002 Mar;49(3):243-8. Kingma JG Jr, Sandhu R, Hamelin ND, Gendron D, Trudel Y, Bosa M, Stewart R, Fargey MB, Biro GP. The effects of hemodilution with Hemolink upon hemodynamics and blood flow distribution in anesthetized dogs. Artif Cells Blood Substit Immobil Biotechnol. 2001 Nov;29(6):465-81. Topfer LA, Hailey D. Oxygen carriers ("blood substitutes"). Issues Emerg Health Technol. 2001 Jul;(21):1-6. Scatena R, Giardina B. O-raffinose-polymerised haemoglobin. A biochemical and pharmacological profile of an oxygen carrier. Expert Opin Biol Ther. 2001 Jan;1(1):121-7. Review. Cheng DC. Safety and efficacy of o-raffinose cross-linked human hemoglobin (Hemolink) in cardiac surgery. Can J Anaesth. 2001 Apr;48(4 Suppl):S41-8. Review. Caron A, Malfatti E, Aguejouf O, Faivre-Fiorina B, Menu P. Vasoconstrictive response of rat mesenteric arterioles following infusion of cross-linked, polymerized, and conjugated hemoglobin solutions. Artif Cells Blood Substit Immobil Biotechnol. 2001 Jan;29(1):19-30. Toussaint M, Latger-Cannard V, Caron A, Lecompte T, Stoltz JF, Vigneron C, Menu P. Effects of three Hb-based oxygen-carrying solutions on neutrophil activation in vitro: quantitative measurement of the expression of adherence receptors. Transfusion. 2001 Feb;41(2):226-31. Carmichael FJ, Ali AC, Campbell JA, Langlois SF, Biro GP, Willan AR, Pierce CH, Greenburg AG. A phase I study of oxidized raffinose cross-linked human hemoglobin. Crit Care Med. 2000 Jul;28(7):2283-92. Cohn SM. Blood substitutes in surgery. Surgery. 2000 Jun;127(6):599-602. Review. No abstract available. Ning J, Wong LT, Christoff B, Carmichael FJ, Biro GP. Haemodynamic response following a 10% topload infusion of HemolinkTM in conscious, anaesthetized and treated spontaneously hypertensive rats. Transfus Med. 2000 Mar;10(1):13-22. Lieberthal W, Fuhro R, Andry C, Valeri CR. Effects of hemoglobin-based oxygen-carrying solutions in anesthetized rats with acute ischemic renal failure. J Lab Clin Med. 2000 Jan;135(1):73-81. Xue S, Paterson W, Valdez D, Miller D, Christoff B, Wong LT, Diamant NE. Effect of an o-raffinose cross-linked haemoglobin product on oesophageal and lower oesophageal sphincter motor function. Neurogastroenterol Motil. 1999 Dec;11(6):421-30. Freilich D, Branda R, Hacker M, Leach L, Barry B, Ferris S, Hebert J. Decreased lactic acidosis and anemia after transfusion of o-raffinose cross-linked and polymerized hemoglobin in severe murine malaria. Am J Trop Med Hyg. 1999 Feb;60(2):322-8. Lieberthal W, Fuhro R, Freedman JE, Toolan G, Loscalzo J, Valeri CR. O-raffinose cross-linking markedly reduces systemic and renal vasoconstrictor effects of unmodified human hemoglobin. J Pharmacol Exp Ther. 1999 Mar;288(3):1278-87. Glaser V. Fake blood market gets hemoglobin transfusion from reticulocytes. Nat Biotechnol. 1998 Aug;16(8):709. No abstract available. Macdonald RL, Zhang J, Weir B, Marton LS, Wollman R. Adenosine triphosphate causes vasospasm of the rat femoral artery. Neurosurgery. 1998 Apr;42(4):825-32; discussion 832-3. Balion CM, Champagne PA, Ali AC. Evaluation of HemogloBind for removal of o-raffinose cross-linked hemoglobin (Hemolink) from serum. Clin Chem. 1997 Sep;43(9):1796-7. No abstract available. Ali AC, Mihas CC, Campbell JA. Interferences of o-raffinose cross-linked hemoglobin in three methods for serum creatinine. Clin Chem. 1997 Sep;43(9):1738-43. Kerger H, Tsai AG, Saltzman DJ, Winslow RM, Intaglietta M. Fluid resuscitation with O2 vs. non-O2 carriers after 2 h of hemorrhagic shock in conscious hamsters. Am J Physiol. 1997 Jan;272(1 Pt 2):H525-37. Baines AD, Christoff B, Wicks D, Wiffen D, Pliura D. Cross-linked hemoglobin increases fractional reabsorption and GFR in hypoxic isolated perfused rat kidneys. Am J Physiol. 1995 Nov;269(5 Pt 2):F628-36. Wong LT, Er SS, Ning J, Christoff B, Carmichael FJ. Hemolink-induced effects on intestinal motor function and attenuation of these effects by selected agents. Artif Cells Blood Substit Immobil Biotechnol. 1998 Nov;26(5-6):529-48. Ali AC, Campbell JA. Interference of o-raffinose cross-linked hemoglobin with routine Hitachi 717 assays. Clin Chem. 1997 Sep;43(9):1794-6. No abstract available. Arnoldo BD, Minei JP. Potential of hemoglobin-based oxygen carriers in trauma patients. Curr Opin Crit Care. 2001 Dec;7(6):431-6. Review. Caron A, Menu P, Faivre-Fiorina B, Labrude P, Alayash AI, Vigneron C. Cardiovascular and hemorheological effects of three modified human hemoglobin solutions in hemodiluted rabbits. J Appl Physiol. 1999 Feb;86(2):541-8. Study ID Numbers HLK-213 Record last reviewed November 2002 NLM Identifier NCT00038454 ClinicalTrials.gov processed this record on 2003-03-19 « Previous Message Next Message » This message (Post #6149767) has been viewed 18 times Report a BullBoards Violation Ignore OwOwOw Post Reply View Threads Go to BullBoard: Symbol Company Name Search by Post ID: 9 Red Flags to Help Spot Message Board Scammers | BullBoards Abbreviations