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

June 23, 2005 updated by: Hemosol

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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:

Study Type

Interventional

Enrollment

180

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, VZ 4E3
        • St. Paul's Hospital/ Vancouver General Hospital
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • The Toronto Hospital - General Division
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Montreal
      • Ste Foy, Quebec, Canada, G1V 4G5
        • Hôpital Laval
  • United Kingdom
    • England
      • London, England, United Kingdom, SE1 7EH
        • St. Thomas Hospital: Department of Anesthesia
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
  • United States
    • California
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Medical Center - San Francisco-Division of Cardiovascular Anesthesia
      • Stanford, California, United States, 94305
        • Stanford University Medical Center: Department of Anesthesiology
    • Florida
      • Sarasota, Florida, United States, 34239
        • Clinical Research Center
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Heart and Vascular Care
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • New Jersey
      • Englewood, New Jersey, United States, 07361
        • Englewood Hospital
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Hospital
    • New York
      • New York, New York, United States, 10029-6574
        • Mount Sinai Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina: Department of Anesthesiology
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Department of Anesthesiology
    • Oregon
      • Portland, Oregon, United States, 97201
        • Veterans Affairs Medical Center
      • Portland, Oregon, United States, 97232
        • Legacy Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Health System
    • Texas
      • Houston, Texas, United States, 77225-0345
        • Cardiovascular Anesthesia Research:Texas Heart Institute
    • Virginia
      • Falls Church, Virginia, United States, 55042-3300
        • Inova Fairfax Hospital
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center
      • Richmond, Virginia, United States, 23298-0695
        • Medical College of Virginia: Department of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hemosol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 30, 2002

First Submitted That Met QC Criteria

May 30, 2002

First Posted (ESTIMATE)

May 31, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLK-213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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