A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume

Phase 2

Completed

Conditions: Bloodloss
Surgical Procedures, Operative

Interventions: Drug: placebo
Drug: ecallantide

Registration Number: NCT00816023

Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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 cardio pulmonary bypass.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 276

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 (<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.]

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	placebo
Ecallantide Medium Dose	ecallantide	target steady state concentration of 0.75 mg/L
Ecallantide Low Dose	ecallantide	target steady state concentration of 0.15 mg/L
Ecallantide High Dose	ecallantide	target steady state concentration of 2.25 mg/L

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Treatment-emergent Adverse Events	Over the duration of the study.

Trial Locations

Locations (29): Cardio-Thoracic Surgeons PC
🇺🇸
Birmingham, Alabama, United States
Drug Research and Analysis Corporation
🇺🇸
Montgomery, Alabama, United States
University of Colorado - Denver
🇺🇸
Aurora, Colorado, United States
Pepin Heart Hospital & Kiran Patel Research Institute
🇺🇸
Tampa, Florida, United States
Indiana Ohio Heart
🇺🇸
Fort Wayne, Indiana, United States
University of Kentucky
🇺🇸
Lexington, Kentucky, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
🇺🇸
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
MCVI - Covenant Medical Center
🇺🇸
Saginaw, Michigan, United States
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Cardio-Thoracic Surgeons PC
🇺🇸Birmingham, Alabama, United States