Status:
COMPLETED
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
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Bloodloss
Surgical Procedures, Operative
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT00888940
Start Date
June 1 2009
End Date
January 1 2010
Last Update
August 10 2015
Active Locations (34)
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1
Cardio-Thoracic Surgeons PC
Birmingham, Alabama, United States, 35205
2
Universitaetsklinikum Aachen AoeR
Aachen, Germany, 52074
3
Klinikum Augsburg
Augsburg, Germany, 86156
4
Herz- und Gefaesszentrum Bad Bevensen
Bad Bevensen, Germany, 29549