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A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume (CONSERV-1)

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ClinicalTrials.gov Identifier: NCT00816023
Recruitment Status : Completed
First Posted : December 31, 2008
Results First Posted : January 12, 2011
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

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.

Condition or disease Intervention/treatment Phase
Bloodloss Surgical Procedures, Operative Drug: ecallantide Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : March 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Ecallantide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ecallantide Low Dose
target steady state concentration of 0.15 mg/L
Drug: ecallantide
infusion administered IV over the duration of the surgical procedure
Experimental: Ecallantide Medium Dose
target steady state concentration of 0.75 mg/L
Drug: ecallantide
infusion administered IV over the duration of the surgical procedure
Experimental: Ecallantide High Dose
target steady state concentration of 2.25 mg/L
Drug: ecallantide
infusion administered IV over the duration of the surgical procedure
Placebo Comparator: Placebo
placebo
Drug: placebo

solution for IV infusion over the duration of the surgical

>> procedure




Primary Outcome Measures :
  1. Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery [ Time Frame: Start of surgery up to 12 hours after the end of surgery ]

Secondary Outcome Measures :
  1. Treatment-emergent Adverse Events [ Time Frame: Over the duration of the study. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816023


  Show 29 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
Study Director: Alistair Wheeler, MD, MFPM Cubist Pharmaceuticals LLC

Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00816023     History of Changes
Other Study ID Numbers: ECAL-PCPB-08-02
First Posted: December 31, 2008    Key Record Dates
Results First Posted: January 12, 2011
Last Update Posted: August 11, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications