Clinical Trial: A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)
Brief Summary: The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.
Detailed Summary: The primary objective is to determine the safety and feasibility of administering Hemopure® (HBOC-201) to reduce myocardial necrosis, as measured by CK-MB enzyme elevation, and enhance tissue preservation during cardiopulmonary bypass.
Sponsor: Biopure Corporation
Current Primary Outcome: Rate of peak CK-MB elevation ≥ 5X upper limit of normal [ Time Frame: Baseline; Peri-op; Days 1,2,3 post procedure; Discharge or Day 6 post procedure(whichever is earlier) ]
Original Primary Outcome: Rate of peak CK-MB elevation ≥ 5 times the upper limit of normal
Current Secondary Outcome: MACE @ discharge and 30 days post surgery; Change in renal function; Renal failure; Increased Cardiac Troponin T; Death rate; MI/stroke; Supplemental RBC transfusions; Total units RBC and HBOC-201; Intra Aortic Balloon Pump use, pump time; New onset CHF [ Time Frame: Duration of the study ]
Original Secondary Outcome:
- Safety:
- • Rate of major adverse cardiac events (MACE) at hospital discharge and 30 days post procedure.
- • Renal failure resulting in one of the following:
- o a new requirement for dialysis
- o increase of serum creatinine to greater than an absolute value of 220 umol/L and two times the baseline creatinine level, but does not require dialysis
- • Rate of Cardiac Troponin T elevation through hospital discharge
- • Individual rates of death, MI and stroke
- Efficacy:
- • Rate of supplemental RBC transfusions
- • Total units RBC or HBOC-201 administered
- • Change in renal function assessed by changes in serum creatinine levels from baseline through hospital discharge
- • Rate of intra-aortic balloon pump (IABP) support and total pump time
- • New onset of congestive heart failure (CHF) through hospital discharge
- • Procedural cross-clamp time
- • Total patient ventilation time
- • Time to hospital discharge
- • Cognitive impairment, defined as change in neurocognitive testing assessment from baseline to hospital discharge
Information By: Biopure Corporation
Dates:
Date Received: March 9, 2006
Date Started: February 2006
Date Completion: September 2008
Last Updated: May 15, 2008
Last Verified: May 2008