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

Study Overview
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Brief Summary
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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

Detailed Description
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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:

Official Title
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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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: Hemolink (hemoglobin raffimer IV solution)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hemolink (hemoglobin raffimer IV solution)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen Therapeutics, CABG, Transfusion