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Clinical Trials: Surgery


A Phase II Multi-Center, Parallel-Group, Randomized, Double Blind, Proof-of-Concept, Adaptive Study Investigating the Safety and Efficacy of THR-184 Administered via Intravenous Infusion in Patients at Increased Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI) (IRB# 524174)

(Heart, Surgery)
  • Principal Investor
    John Rousou, MD
  • Summary

    The purpose of this study is to see if an investigational medication is effective to prevent acute kidney injury in patients who are undergoing cardiac surgery. 


    Subjects will receive 4 doses in total investigational drug of either THR-184 (2 different dose levels) or placebo.


    Subjects will be followed until 90 Days after surgery for safety measurements.

  • More Information

    Eligibility

    In order to participate in this trial you must be at least 18 years old and having open heart surgery. Participants must meet eligibility requirements that deem them to be at risk for acute kidney injury post-operatively.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Courtney Reyes, RN
    413.794.2412

A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix ECM for Pericardial Reconstruction (IRB# 589061)

(Heart, Surgery)
  • Principal Investor
    David Deaton, MD
  • Summary

    The purpose of this study is to gather additional information on CorMatrix ECM for Pericardial Closure.  This device has received FDA clearance and is intended to close and repair of the sac surrounding the heart during cardiac surgery. To participate in this study, the CorMatrix ECM device must be used during cardiac surgery. 

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305
    Email