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

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00816023
First received: December 29, 2008
Last updated: December 14, 2010
Last verified: December 2010
  Purpose

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 Intervention Phase
Bloodloss
Surgical Procedures, Operative
Drug: ecallantide
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment-emergent Adverse Events [ Time Frame: Over the duration of the study. ] [ Designated as safety issue: Yes ]

Enrollment: 276
Study Start Date: March 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816023

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

No publications provided

Responsible Party: Ed Campanaro/Vice President, Clinical Operations and Data Management, Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00816023     History of Changes
Other Study ID Numbers: ECAL-PCPB-08-02
Study First Received: December 29, 2008
Results First Received: December 14, 2010
Last Updated: December 14, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 18, 2014