Status:
COMPLETED
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Bloodloss
Surgical Procedures, Operative
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of ca...
Eligibility Criteria
Inclusion
- Written informed consent (by study subject or appropriate legal representative) prior to any study-related procedure not part of normal medical care
- Planned primary CABG surgery including the use of cardio-pulmonary bypass.
Exclusion
- Planned concomitant surgery including ASD repair, valve replacement, carotid endarterectomy, CABG combined procedures or any repeat sternotomy;
- Body weight \<55 kg;
- Planned hypothermia (\<28ºC);
- Planned transfusion in the peri-operative or post-operative periods;
- Planned transfusion of pre-operatively donated autologous blood;
- Female subjects who are pregnant or lactating;
- Planned use of desmopressin, lysine analogs, atrial natriuretic hormone or recombinant activated Factor VII;
- Planned use of corticosteroids in the pump prime solution;
- Ejection fraction \<30% within 90 days prior to surgery;
- Evidence of a myocardial infarction within 5 days prior to surgery;
- History of stroke or transient ischemic attack within 3 months prior to surgery;
- Hypotension or heart failure requiring the use of inotropes or mechanical devices within 24 hours prior to surgery;
- Serum creatinine \>2.0 mg/dL within 48 hours prior to surgery;
- Serum hepatic enzymes above 2.5 times the upper limit of normal for the applicable laboratory;
- Hematocrit \<32% within 48 hours prior to surgery;
- Platelet count below the normal range for the applicable laboratory within 14 days prior to surgery;
- History of, or family history of, bleeding or clotting disorder or thrombophilia;
- History of heparin-induced thrombocytopenia;
- Prothrombin time and/or activated partial thromboplastin time \>1.5 X normal range;
- Serious intercurrent illness or active infection;
- Any previous exposure to ecallantide;
- Receipt of an investigational drug or device 30 days prior to participation in the current study;
- Known allergy to any agent expected to be used in the intra-operative or post-operative periods; and
- Administration of: Eptifibatide within 6 hours prior to surgery, Tirofiban HCl within 6 hours prior to surgery, \*Enoxaparin sodium or other low-molecular-weight heparin \<24 hours prior to surgery, Clopidogrel within 5 days prior to surgery, Ticlopidine within 7 days prior to surgery, Abciximab within 5 days prior to surgery, \*Bivalirudin, argatroban or lepirudin within 6 hours prior to surgery, \*Fondaparinux within 72 hours prior to surgery, Prasugrel within 10 days prior to surgery \[\*Prophylactic use permitted for the prevention of deep vein thrombosis.\]
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00816023
Start Date
March 1 2009
End Date
January 1 2010
Last Update
August 11 2015
Active Locations (29)
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1
Cardio-Thoracic Surgeons PC
Birmingham, Alabama, United States, 35205
2
Drug Research and Analysis Corporation
Montgomery, Alabama, United States, 36106
3
University of Colorado - Denver
Aurora, Colorado, United States, 80045
4
Pepin Heart Hospital & Kiran Patel Research Institute
Tampa, Florida, United States, 33613