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

July 21, 2015 updated by: Cubist Pharmaceuticals LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
276

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hospital Laval)
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • New Brunswick Heart Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8L 5G4
        • Hamilton Health Sciences
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M5B 18W
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Cardio-Thoracic Surgeons PC
      • Montgomery, Alabama, United States, 36106
        • Drug Research and Analysis Corporation
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado - Denver
    • Florida
      • Tampa, Florida, United States, 33613
        • Pepin Heart Hospital & Kiran Patel Research Institute
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Indiana Ohio Heart
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02135
        • Caritas St. Elizabeth's Medical Center
    • Michigan
      • Saginaw, Michigan, United States, 48601
        • MCVI - Covenant Medical Center
      • Saginaw, Michigan, United States, 48601
        • MCVI - St. Mary's of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University
      • New York, New York, United States, 10025
        • St. Luke's - Roosevelt Hospital Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Baptist Medical Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • East Tennessee Cardiovascular Surgery Group
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Heart Institute
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Heart Hospital
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center (CAMC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
placebo
Drug: placebo
solution for IV infusion over the duration of the surgical>> procedure
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Start of surgery up to 12 hours after the end of surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Treatment-emergent Adverse Events
Time Frame: Over the duration of the study.
Over the duration of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cubist Pharmaceuticals LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alistair Wheeler, MD, MFPM, Cubist Pharmaceuticals LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECAL-PCPB-08-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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