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

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hemosol

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.