Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery (CONSERV-2)

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00888940
First received: April 26, 2009
Last updated: May 24, 2011
Last verified: May 2011
  Purpose

A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding


Condition Intervention Phase
Bloodloss
Surgical Procedures, Operative
Drug: Ecallantide
Drug: Cyklokapron(R)
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 - 2 (Clinical Outcomes and Safety Trial to Investigate Ecallantide's Effect on Reducing Surgical Blood Loss Volume) - A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Cumulative Volume of Packed Red Blood Cells Transfused [ Time Frame: 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: 243
Study Start Date: June 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ecallantide Drug: Ecallantide
2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
Active Comparator: Cyklokapron(R) Drug: Cyklokapron(R)
1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime

  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) prior to any study-related procedure not part of normal medical care;
  • Male or female between the ages of 18 and 85 years old, inclusive; and
  • Planned cardiac surgery using cardio-pulmonary bypass, for one of the following procedures: any repeat sternotomy; surgery to repair or replace more than one valve; combined CABG plus repair or replacement of at least one valve
  • If female, subject is non-lactating, and is either:Not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy;Of childbearing potential but is not pregnant as confirmed by negative pregnancy test at time of screening (based on the β-subunit of HCG), and is practicing the barrier method of birth control along with one of the following methods: oral or parenteral contraceptives for three months prior to study drug administration, a vasectomized partner, or abstinence from sexual intercourse.

Exclusion Criteria:

  • Planned primary CABG, single valve repair or replacement surgery, or any off pump procedure;
  • 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 (other than study medication), 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 (aspartate aminotransferase or alanine aminotransferase) 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 (e.g. von Willebrand's Disease, idiopathic thrombocytopenia purpura) or thrombophilia such as anti-thrombin III deficiency or Factor V Leiden mutation;
  • History of heparin-induced thrombocytopenia;
  • Prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) >1.5 X normal range unless subject received heparin within 24 hours of test;
  • Serious intercurrent illness or active infection (e.g. endocarditis, sepsis, active malignancy requiring treatment);
  • Any previous exposure to ecallantide;
  • Receipt of an investigational drug or device 30 days prior to participation in the current study;
  • Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study;
  • Inability to comply with the protocol for the duration of the 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 hydrochloride within 6 hours prior to surgery, (Enoxaparin sodium or other low-molecular-weight heparin <24 hours prior to surgery), Prasugrel within 10 days prior to surgery, Clopidogrel within 3 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), Chlorpromazine within 7 days prior to surgery (Prophylactic use permitted for the prevention of deep vein thrombosis.)
  • Planned use of heparin bonded bypass circuits;
  • Known allergy or hypersensitivity to tranexamic acid or any of the other ingredients;
  • Disturbance of color sense;
  • Evidence of hematuria or any acute thromboses or thromboembolic diseases such as deep vein thrombosis, pulmonary embolism, or vertebral 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: NCT00888940

Locations
United States, Alabama
Cardio-Thoracic Surgeons PC
Birmingham, Alabama, United States, 35205
Germany
Universitaetsklinikum Aachen AoeR
Aachen, Germany, 52074
Klinikum Augsburg
Augsburg, Germany, 86156
Herz- und Gefaesszentrum Bad Bevensen
Bad Bevensen, Germany, 29549
Universitaetsklinikum Bonn
Bonn, Germany, 53105
Klinik und Poliklinik fuer Herz- und Thoraxchirurgie der Universitaet zu Koeln
Cologne, Germany, 50937
St. Johannes Hospital
Dortmund, Germany, 44137
Herzzentrum Dresden GmbH Universitaetsklinik
Dresden, Germany, 01307
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Universitaetsklinikum Frankfurt
Frankfurt, Germany, 60590
Universitaetsklinikum Freiburg
Freiburg, Germany, 79106
Universitaetsmedizin Goettingen
Goettingen, Germany, 37075
Universitaetsklinikum Halle (Saale)
Halle, Germany, 06120
Universitaeres Herzzentrum Hamburg GmbH
Hamburg, Germany, 20246
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, Germany, 67063
Klinik fuer Herzchirurgie des Universitaetsklinikum SH
Luebeck, Germany, 23538
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Universitaetsklinikum Wuerzburg
Wuerzburg, Germany, 97080
HELIOS Klinik Wuppertal
Wuppertal, Germany, 42117
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland, 15-276
Szpital Uniwersytecki im. Dr. Antoniego Jurasza w Bydgoszczy
Bydgoszcz, Poland, 85-094
Akademickie Centrum Kliniczne, Szpital AM w Gdansku
Gdansk, Poland, 80-952
Samodzielny Publiczny Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland, 40-635
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Kraków, Poland, 31-200
Uniwersytecki Szpital Kliniczny Nr. 3 im. Dr Seweryna Sterlinga
Lódz, Poland, 91-425
Katedra Chorób Serca AM, Szpital Miejski im. J Strusia
Poznan, Poland, 61-833
Samodzielny Publiczny Szpital Kliniczny Nr 2 Pomorskiej Akademii Medycznej
Szczecin, Poland, 70-111
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON
Warszawa, Poland, 04-414
Instytut Kardiologii im. Prymasa Tysiclecia Stefana Kardynała Wyszyńskiego
Warszawa, Poland, 04-628
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Wroclaw, Poland, 50-369
4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ, Centrum Chorób Serca
Wroclaw, Poland, 50-981
Slaskie Centrum Chorób Serca
Zabrze, Poland, 41-800
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Alistair Wheeler, MD, MFPM Cubist Pharmaceuticals
  More Information

No publications provided by Cubist Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edward Campanaro, Vice President Clinical Operations and Data Management, Cubist Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00888940     History of Changes
Other Study ID Numbers: ECAL-CCPB-08-07
Study First Received: April 26, 2009
Results First Received: December 14, 2010
Last Updated: May 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014