Clinical trial NCT00816023: A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
Official title: CONSERV-1 (Clinical Outcomes and Safety Trial to Investigate Ecallantide's Effect on Reducing Surgical Blood Loss Volume) A Phase 2 Randomized Placebo-controlled Dose-ranging Study in Subjects Exposed to Cardio-pulmonary Bypass During Primary Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bloodloss
Surgical Procedures, Operative
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2008-12-31
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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 \[\*Prophylactic use permitted for the prevention of deep vein thrombosis.\]

Primary outcomes:
measure: Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery
timeFrame: Start of surgery up to 12 hours after the end of surgery
Secondary outcomes:
measure: Treatment-emergent Adverse Events
timeFrame: Over the duration of the study.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardio-Thoracic Surgeons PC
state: Alabama
city: Montgomery
country: United States
facility: Drug Research and Analysis Corporation
state: Alabama
city: Aurora
country: United States
facility: University of Colorado - Denver
state: Colorado
city: Tampa
country: United States
facility: Pepin Heart Hospital & Kiran Patel Research Institute
state: Florida
city: Fort Wayne
country: United States
facility: Indiana Ohio Heart
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Saginaw
country: United States
facility: MCVI - Covenant Medical Center
state: Michigan
city: Saginaw
country: United States
facility: MCVI - St. Mary's of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: St. Luke's - Roosevelt Hospital Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Knoxville
country: United States
facility: East Tennessee Cardiovascular Surgery Group
state: Tennessee
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Norfolk
country: United States
facility: Sentara Heart Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center (CAMC)
state: West Virginia
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Saint John
country: Canada
facility: New Brunswick Heart Centre
state: New Brunswick
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hospital Laval)
Study officials:
affiliation: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
name: Alistair Wheeler, MD, MFPM
role: STUDY_DIRECTOR
References: