Clinical Trials

A Phase 2, Randomized, Double Blind, Placebo Controlled Study of the Safety and Efficacy of Human Recombinant Soluble Complement Receptor Type I (TP 10) in Adult Women Undergoing Cardiopulmonary Bypass Surgery

During a heart bypass procedure, a substance called “complement” is released by the body. This substance causes inflammation, which can lead to side effects such as chest pain, heart attacks, and/or heart failure. The purpose of this study is to determine whether the study drug, TP 10, which is investigational, can block the release of complement and in so doing reduce post operative side effects. This experimental drug, TP 10, may help prevent complications experienced by patients who under go cardiac surgery with cardiopulmonary bypass (CPB). In a previous study, women were under-represented and therefore only women will be entered into this present study.

Eligibility for enrollment:

• Be female and >18 years of age
• Require cardiopulmonary bypass grafting on pump for any of the following:
  • Prior heart surgery
  • Severe chest pain
  • CABG and heart valve surgery
• Agree to be followed for 30 days after surgery
• Provide Informed Consent

Primary Investigator: Vaughn A. Starnes, MD

Co-Investigators: Mark J. Cunningham, MD, Steven Haddy, MD

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