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

Paused · Phase 2/Phase 3

Conditions studied: Cardiovascular Disease

In brief

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

Key facts

Study ID

NCT00038454

Run by

Hemosol

People needed

180

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Kaiser Permanente Medical Center - San Francisco-Division of Cardiovascular Anesthesia — San Francisco, California, United States
• Stanford University Medical Center: Department of Anesthesiology — Stanford, California, United States
• Clinical Research Center — Sarasota, Florida, United States
• Heart and Vascular Care — Des Moines, Iowa, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Englewood Hospital — Englewood, New Jersey, United States
• Robert Wood Johnson Hospital — New Brunswick, New Jersey, United States
• Mount Sinai Medical Center — New York, New York, United States
• University of North Carolina: Department of Anesthesiology — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Ohio State University Department of Anesthesiology — Columbus, Ohio, United States
• Veterans Affairs Medical Center — Portland, Oregon, United States
• Legacy Research — Portland, Oregon, United States
• UPMC Health System — Pittsburgh, Pennsylvania, United States
• Cardiovascular Anesthesia Research:Texas Heart Institute — Houston, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• McGuire VA Medical Center — Richmond, Virginia, United States
• Medical College of Virginia: Department of Anesthesiology — Richmond, Virginia, United States
• Foothills Medical Centre — Calgary, Alberta, Canada
• St. Paul's Hospital/ Vancouver General Hospital — Vancouver, British Columbia, Canada
• Kingston General Hospital — Kingston, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• The Toronto Hospital - General Division — Toronto, Ontario, Canada
• Institut de Cardiologie de Montreal — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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