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

Surgical Procedures, Operative Clinical Trial

— CONSERV-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816023
• Other study ID #: ECAL-PCPB-08-02
• 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 (<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

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Bloodloss
• Surgical Procedures, Operative

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