NCT00816023

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

Geographic Reach
2 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 12, 2011

Completed
Last Updated

August 11, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

December 29, 2008

Results QC Date

December 14, 2010

Last Update Submit

July 21, 2015

Conditions

BloodlossSurgical Procedures, Operative

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Treatment-emergent Adverse Events

    Over the duration of the study.

Study Arms (4)

Ecallantide Low Dose

EXPERIMENTAL

target steady state concentration of 0.15 mg/L

Drug: ecallantide

Ecallantide Medium Dose

EXPERIMENTAL

target steady state concentration of 0.75 mg/L

Drug: ecallantide

Ecallantide High Dose

EXPERIMENTAL

target steady state concentration of 2.25 mg/L

Drug: ecallantide

Placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

ecallantideDRUG

infusion administered IV over the duration of the surgical procedure

Ecallantide High DoseEcallantide Low DoseEcallantide Medium Dose
placeboDRUG

solution for IV infusion over the duration of the surgical\>\> procedure

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Cardio-Thoracic Surgeons PC

Birmingham, Alabama, 35205, United States

Location

Drug Research and Analysis Corporation

Montgomery, Alabama, 36106, United States

Location

University of Colorado - Denver

Aurora, Colorado, 80045, United States

Location

Pepin Heart Hospital & Kiran Patel Research Institute

Tampa, Florida, 33613, United States

Location

Indiana Ohio Heart

Fort Wayne, Indiana, 46804, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MCVI - Covenant Medical Center

Saginaw, Michigan, 48601, United States

Location

MCVI - St. Mary's of Michigan

Saginaw, Michigan, 48601, United States

Location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

St. Luke's - Roosevelt Hospital Center

New York, New York, 10025, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

East Tennessee Cardiovascular Surgery Group

Knoxville, Tennessee, 37920, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Sentara Heart Hospital

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Charleston Area Medical Center (CAMC)

Charleston, West Virginia, 25304, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

New Brunswick Heart Centre

Saint John, New Brunswick, E2L 4L2, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 5G4, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 18W, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Hospital Laval)

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Interventions

ecallantide

Limitations and Caveats

Secondary efficacy variables were considered exploratory and, based on failure of the primary endpoint to meet statistical significance and early termination of the trial, are not presented.

Results Point of Contact

Title
Alistair Wheeler, MD, MFPM, Senior Director Clinical Research
Organization
Cubist Pharmaceuticals, Inc.
awheeler@cubist.com
781-860-8660

Study Officials

  • Alistair Wheeler, MD, MFPM

    Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2008

First Posted

December 31, 2008

Study Start

March 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

August 11, 2015

Results First Posted

January 12, 2011

Record last verified: 2015-07

Locations

CA(8)US(21)