EUCTR2008-008354-23-DE进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent (by study subject) prior to any study-related procedure not part of normal medical
- •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
排除标准
- •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.
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