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Cardiovascular DiseasePhase 2/3NCT00038454

Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery

A Phase 2/3 study testing Hemolink (hemoglobin raffimer IV solution) in people with Cardiovascular Disease, run by Hemosol at 28 sites in 3 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cardiovascular Disease
What is being tested?
Hemolink (hemoglobin raffimer IV solution)
Type of treatment
Injection or infusion
How many people
180 participants
Where
28 sitesin 3 countries
Study dates
Start not givento not given
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

28 sites in 3 countries.

28 sites in 3 countries

United States19 sites

  • University of North Carolina: Department of Anesthesiology

    Chapel Hill, North Carolina, 27514

  • The Ohio State University Department of Anesthesiology

    Columbus, Ohio, 43210

  • Heart and Vascular Care

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Englewood Hospital

    Englewood, New Jersey, 07361

  • Inova Fairfax Hospital

    Falls Church, Virginia, 55042-3300

  • Cardiovascular Anesthesia Research:Texas Heart Institute

    Houston, Texas, 77225-0345

  • Robert Wood Johnson Hospital

    New Brunswick, New Jersey, 08901

  • Mount Sinai Medical Center

    New York, New York, 10029-6574

  • UPMC Health System

    Pittsburgh, Pennsylvania, 15213

  • Veterans Affairs Medical Center

    Portland, Oregon, 97201

  • Legacy Research

    Portland, Oregon, 97232

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Medical College of Virginia: Department of Anesthesiology

    Richmond, Virginia, 23298-0695

  • Kaiser Permanente Medical Center - San Francisco-Division of Cardiovascular Anesthesia

    San Francisco, California, 94115

  • Clinical Research Center

    Sarasota, Florida, 34239

  • Washington University

    St Louis, Missouri, 63110

  • Stanford University Medical Center: Department of Anesthesiology

    Stanford, California, 94305

Other trials in United States

Canada7 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Institut de Cardiologie de Montreal

    Montreal, Quebec, H1T 1C8

  • Hopital Laval

    Ste Foy, Quebec, G1V 4G5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • The Toronto Hospital - General Division

    Toronto, Ontario, M5G 2C4

  • St. Paul's Hospital/ Vancouver General Hospital

    Vancouver, British Columbia, VZ 4E3

Other trials in Canada

United Kingdom2 sites

  • St. Thomas Hospital: Department of Anesthesia

    London, England, SE1 7EH

  • Southampton General Hospital

    Southampton, England, SO16 6YD

Other trials in United Kingdom

About this 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

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

Read the detailed description

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:

Being tested
Hemolink (hemoglobin raffimer IV solution)
Keywords
Oxygen Therapeutics, CABG, Transfusion
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hemolink (hemoglobin raffimer IV solution)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2002 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Enrolment
180 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00038454
Sponsor's protocol ID
HLK-213
Status last verified
Apr 2003
First submitted
30 May 2002
Last updated
24 Jun 2005
Results posted
No

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. doi: 10.1007/BF03020522.

    PubMed 11861341

  • 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. doi: 10.1081/bio-100108551.

    PubMed 11795632

  • Topfer LA, Hailey D. Oxygen carriers ("blood substitutes"). Issues Emerg Health Technol. 2001 Jul;(21):1-6.

    PubMed 11776287

  • 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. doi: 10.1517/14712598.1.1.121.

    PubMed 11727541

  • 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.

    PubMed 11336436

  • 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. doi: 10.1081/bio-100001253.

    PubMed 11280681

  • 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. doi: 10.1046/j.1537-2995.2001.41020226.x.

    PubMed 11239227

  • 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. doi: 10.1097/00003246-200007000-00017.

    PubMed 10921554

  • Cohn SM. Blood substitutes in surgery. Surgery. 2000 Jun;127(6):599-602. doi: 10.1067/msy.2000.106462. No abstract available.

    PubMed 10840352

  • 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. doi: 10.1046/j.1365-3148.2000.00225.x.

    PubMed 10760199

  • 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. doi: 10.1016/s0022-2143(00)70023-0.

    PubMed 10638697

  • 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. doi: 10.1046/j.1365-2982.1999.00171.x.

    PubMed 10583849

  • 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. doi: 10.4269/ajtmh.1999.60.322.

    PubMed 10072160

  • 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.

    PubMed 10027869

  • Glaser V. Fake blood market gets hemoglobin transfusion from reticulocytes. Nat Biotechnol. 1998 Aug;16(8):709. doi: 10.1038/nbt0898-709. No abstract available.

    PubMed 9702757

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Hemolink (hemoglobin raffimer IV solution) in people with Cardiovascular Disease, run by Hemosol at 28 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00038454, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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