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Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery Clinical research trials and Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery. Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery clinical trial. Human subjects often receive the most effective healthcare possible for their Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery  Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery
Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery
For Condition: Cardiovascular Disease
Status: Suspended
Sponsor(s): Hemosol ,
Synopsis: To evaluate the efficacy of Hemolinkâ„¢ in combination with Intraoperative Autologous Donation (IAD) versus control (IAD alone) in facilitating avoidance of allogeneic RBC transfusion during and following primary CABG surgery
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:
Study Type: Interventional, Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 180
Location and Contact Information:
Stanford University Medical Center: Department of Anesthesiology
Stanford, California, 94305
United States
Heart and Vascular Care
Des Moines, Iowa, 50314
United States
Mount Sinai Medical Center
New York City, New York, 10029-6574
United States
Clinical Research Center
Sarasota, Florida, 34239
United States
UPMC Health System
Pittsburgh, Pennsylvania, 15213
United States
St. Paul's Hospital/ Vancouver General Hospital
Vancouver, British Columbia, VZ 4E3
Canada
The Ohio State University Department of Anesthesiology
Columbus, Ohio, 43210
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Medical College of Virginia: Department of Anesthesiology
Richmond, Virginia, 23298-0695
United States
Cardiovascular Anesthesia Research:Texas Heart Institute
Houston, Texas, 77225-0345
United States
McGuire VA Medical Center
Richmond, Virginia, 23249
United States
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8
Canada
Southampton General Hospital
Southampton, England, SO16 6YD
United Kingdom
Inova Fairfax Hospital
Falls Church, Virginia, 55042-3300
United States
Veterans Affairs Medical Center
Portland, Oregon, 97201
United States
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Canada
Kaiser Permanente Medical Center - San Francisco-Division of Cardiovascular Anesthesia
San Francisco, California, 94115
United States
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Canada
Robert Wood Johnson Hospital
New Brunswick, New Jersey, 08901
United States
Englewood Hospital
Englewood, New Jersey, 07361
United States
St. Thomas Hospital: Department of Anesthesia
London, England, SE1 7EH
United Kingdom
Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
University of North Carolina: Department of Anesthesiology
Chapel Hill, North Carolina, 27514
United States
Washington University
St. Louis, Missouri, 63110
United States
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Canada
Legacy Research
Portland, Oregon, 97232
United States
The Toronto Hospital - General Division
Toronto, Ontario, M5G 2C4
Canada
Duke University Medical Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: HLK-213;
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038454
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Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery
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