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
- Conditions
- Surgical Procedures, OperativeBloodloss
- Interventions
- Drug: Cyklokapron(R)
- Registration Number
- NCT00888940
- Lead Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Brief Summary
A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cyklokapron(R) Cyklokapron(R) - ecallantide Ecallantide -
- Primary Outcome Measures
Name Time Method Cumulative Volume of Packed Red Blood Cells Transfused 12 hours after the end of surgery
- Secondary Outcome Measures
Name Time Method Treatment-emergent Adverse Events. Over the duration of the study.
Trial Locations
- Locations (34)
Cardio-Thoracic Surgeons PC
🇺🇸Birmingham, Alabama, United States
Herz- und Gefaesszentrum Bad Bevensen
🇩🇪Bad Bevensen, Germany
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
Universitaetsklinikum Aachen AoeR
🇩🇪Aachen, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
St. Johannes Hospital
🇩🇪Dortmund, Germany
Klinik und Poliklinik fuer Herz- und Thoraxchirurgie der Universitaet zu Koeln
🇩🇪Cologne, Germany
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
Herzzentrum Dresden GmbH Universitaetsklinik
🇩🇪Dresden, Germany
Universitaetsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitaetsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Universitaetsklinikum Halle (Saale)
🇩🇪Halle, Germany
Universitaetsmedizin Goettingen
🇩🇪Goettingen, Germany
Klinikum der Stadt Ludwigshafen gGmbH
🇩🇪Ludwigshafen, Germany
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitaeres Herzzentrum Hamburg GmbH
🇩🇪Hamburg, Germany
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Germany
Deutsches Herzzentrum Muenchen
🇩🇪Munich, Germany
Klinik fuer Herzchirurgie des Universitaetsklinikum SH
🇩🇪Luebeck, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
HELIOS Klinik Wuppertal
🇩🇪Wuppertal, Germany
Akademickie Centrum Kliniczne, Szpital AM w Gdansku
🇵🇱Gdansk, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
🇵🇱Kraków, Poland
Katedra Chorób Serca AM, Szpital Miejski im. J Strusia
🇵🇱Poznan, Poland
Instytut Kardiologii im. Prymasa Tysiclecia Stefana Kardynała Wyszyńskiego
🇵🇱Warszawa, Poland
4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ, Centrum Chorób Serca
🇵🇱Wroclaw, Poland
Slaskie Centrum Chorób Serca
🇵🇱Zabrze, Poland
Szpital Uniwersytecki im. Dr. Antoniego Jurasza w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON
🇵🇱Warszawa, Poland
Samodzielny Publiczny Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach
🇵🇱Katowice, Poland
Uniwersytecki Szpital Kliniczny Nr. 3 im. Dr Seweryna Sterlinga
🇵🇱Lódz, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2 Pomorskiej Akademii Medycznej
🇵🇱Szczecin, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
🇵🇱Wroclaw, Poland