CONSERV TM – 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 - CONSERV TM - 2

• Conditions: Reduction of blood loss in subjects exposed to CPB during cardiac surgery at high risk for bleeding; MedDRA version: 9.1Level: LLTClassification code 10036277Term: Postoperative bleeding

• Registration Number: EUCTR2008-008354-23-DE
• Lead Sponsor: Cubist Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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 hysterectomy;
• 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

1. Planned primary CABG, single valve repair or replacement surgery, or any off-pump procedure;
2. Body weight <55 kg;
3. Planned hypothermia (<28ºC);
4. Planned transfusion of donated banked blood in the peri-operative or post-operative periods;
5. Planned transfusion of pre-operatively donated autologous blood;
6. Female subjects who are pregnant or lactating;
7. Planned use of desmopressin, lysine analogs (other than study medication), atrial natriuretic hormone or recombinant activated Factor VII;
8. Planned use of corticosteroids in the pump prime solution;
9. Ejection fraction <30% within 90 days prior to surgery;
10. Evidence of a myocardial infarction within 5 days prior to surgery;
11. History of stroke or transient ischemic attack within 3 months prior to surgery;
12. Hypotension or heart failure requiring the use of inotropes or mechanical devices within 24 hours prior to surgery;
13. Serum creatinine >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 <32% within 48 hours prior to surgery;
16. Platelet count below the normal range for the applicable laboratory within 14 days prior to surgery;
17. 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;
18. History of heparin-induced thrombocytopenia;
19. Prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) >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;
26. 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.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified