Reduction of blood loss in subjects exposed to CPB during cardiac surgery at high risk for bleeding
Conditions
Interventions
Product Name: Ecallantide
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ecallantide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number:
Sponsors
Cubist Pharmaceuticals,INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent (by study subject) prior to any study-related procedure not part of normal medical care; 2. Male or female between the ages of 18 and 85 years old, inclusive; and 3. 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 4. 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 historectomy; • Of childbearing potential but is not pregnant as confirmed by negative pregnancy test at time of screening (based on the ß-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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Planned primary CABG, single valve repair or replacement surgery, or any off pump procedure; 2. Body weight 2.0 mg/dL within 48 hours prior to surgery; 14. Serum hepatic enzymes (aspartate aminotransferase or alanine aminotransferase) above 2.5 times the upper limit of normal for the applicable laboratory; 15. Hematocrit 1.5 X normal range unless subject received heparin within 24 hours of test; 20. Serious intercurrent illness or active infection (e.g. endocarditis, sepsis, active malignancy requiring treatment); 21. Any previous exposure to ecallantide; 22. Receipt of an investigational drug or device 30 days prior to participation in the current study; 23. 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; 24. Inability to comply with the protocol for the duration of the study; 25. Known allergy to any agent expected to be used in the intra-operative or post-operative periods; and 26. Administration of: a. Eptifibatide within 6 hours prior to surgery b. Tirofiban hydrochloride within 6 hours prior to surgery c. *Enoxaparin sodium or other low-molecular-weight heparin <24 hours prior to surgery d. Prasugrel within 10 days prior to surgery e. Clopidogrel within 3 days prior to surgery f. Ticlopidine within 7 days prior to surgery g. Abciximab within 5 days prior to surgery h. *Bivalirudin, argatroban or lepirudin within 6 hours prior to surgery i. *Fondaparinux within 72 hours prior to surgery j. Chlorpromazine within 7 days prior to surgery *Prophylactic use permitted for the prevention of deep vein thrombosis. 27. Planned use of heparin bonded bypass circuits; 28. Known allergy or hypersensitivity to tranexamic acid or any of the other ingredients; 29. Disturbance of color sense; 30. Evidence of hematuria or any acute thromboses or thromboembolic diseases such as deep vein thrombosis, pulmonary embolism, or vertebral vein thrombosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the relative efficacy of ecallantide and tranexamic acid in the reduction of blood loss in subjects undergoing cardiac surgery including the use of CPB, associated with a high risk of bleeding.;Secondary Objective: • To assess the safety of ecallantide in subjects undergoing cardiac surgery including the use of CPB, associated with a high risk of bleeding; • To explore clinical outcomes that may correlate with blood loss in subjects undergoing cardiac surgery including the use of CPB, associated with a high risk of bleeding. ;Primary end point(s): The key variables of interest include the following: • Volume of packed red blood cells administered from the start of surgery up to 12 hours after the end of surgery; • Volume of packed red blood cells administered at each of the following timepoints: during surgery, within 24 hours after the end of surgery and at discharge; • Volume of blood products (platelets and FFP) and related products (albumin) administered during surgery and within 12 and 24 hours after the end of surgery and at discharge; • Administration of blood or blood products at each of the following timepoints; during surgery, within 12 hours after the end of surgery, within 24 hours after the end of surgery and at discharge; • Cumulative volume of chest tube drainage from insertion until 12 and until 24 hours after the end of surgery; • Change in serum creatinine over the duration of the study; and • MI (adjudicated) | — |
Countries
Germany, Poland
Outcome results
None listed