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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00816023
Other study ID # ECAL-PCPB-08-02
Secondary ID
Status Completed
Phase Phase 2
First received December 29, 2008
Last updated July 21, 2015
Start date March 2009
Est. completion date January 2010

Study information

Verified date July 2015
Source Cubist Pharmaceuticals LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial 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 cardio pulmonary bypass.


Recruitment information / eligibility

Status Completed
Enrollment 276
Est. completion date January 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- 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 Criteria:

- Planned concomitant surgery including ASD repair, valve replacement, carotid endarterectomy, CABG combined procedures or any repeat sternotomy;

- Body weight <55 kg;

- Planned hypothermia (<28ÂșC);

- 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.]

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Drug:
ecallantide
infusion administered IV over the duration of the surgical procedure
placebo
solution for IV infusion over the duration of the surgical >> procedure

Locations

Country Name City State
Canada Foothills Medical Centre Calgary Alberta
Canada Hamilton Health Sciences Hamilton Ontario
Canada Montreal Heart Institute Montreal Quebec
Canada Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hospital Laval) Quebec
Canada New Brunswick Heart Centre Saint John New Brunswick
Canada St. Michael's Hospital Toronto Ontario
Canada Toronto General Hospital Toronto Ontario
Canada St. Boniface General Hospital Winnipeg Manitoba
United States University of Colorado - Denver Aurora Colorado
United States Cardio-Thoracic Surgeons PC Birmingham Alabama
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Caritas St. Elizabeth's Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Charleston Area Medical Center (CAMC) Charleston West Virginia
United States Duke University Medical Center Durham North Carolina
United States Indiana Ohio Heart Fort Wayne Indiana
United States Texas Heart Institute Houston Texas
United States East Tennessee Cardiovascular Surgery Group Knoxville Tennessee
United States University of Kentucky Lexington Kentucky
United States Drug Research and Analysis Corporation Montgomery Alabama
United States St. Luke's - Roosevelt Hospital Center New York New York
United States Weill Medical College of Cornell University New York New York
United States Sentara Heart Hospital Norfolk Virginia
United States Integris Baptist Medical Center Oklahoma City Oklahoma
United States Virginia Commonwealth University Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States MCVI - Covenant Medical Center Saginaw Michigan
United States MCVI - St. Mary's of Michigan Saginaw Michigan
United States Pepin Heart Hospital & Kiran Patel Research Institute Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Cubist Pharmaceuticals LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery Start of surgery up to 12 hours after the end of surgery No
Secondary Treatment-emergent Adverse Events Over the duration of the study. Yes
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