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