Status:
TERMINATED
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Lead Sponsor:
Critical Therapeutics
Conditions:
Coronary Disease
Heart Valve Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postope...
Eligibility Criteria
Inclusion
- Parsonnet additive risk score greater than or equal to 15
- Scheduled CABG (coronary artery bypass grafting) and/or cardiac valve repair or replacement surgery using cardiopulmonary bypass
Exclusion
- Emergency cardiac surgery
- Significant concomitant surgery
- Minimally invasive or thoracic surgical approach
- Preoperative mechanical assist device
- Body weight \<50 kg or \>140 kg
- Active systemic infection
- Creatinine \>3.0 mg/dL
- History of hematologic or coagulation disorders
- History of malignancy (past year)or organ transplantation
- Use of immunosuppressive drugs or current immunosuppressed condition
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00107666
Start Date
April 1 2005
End Date
April 1 2006
Last Update
March 17 2006
Active Locations (17)
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1
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
2
University of Southern California
Los Angeles, California, United States, 90033
3
Kaiser Permanente
San Francisco, California, United States, 94115
4
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010