EUCTR2012-002251-42-ES进行中（未招募）1 期
A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PHASE 3 STUDY TO ASSESS THE SAFETY AND EFFICACY OF ART-123 IN SUBJECTS WITH SEVERE SEPSIS AND COAGULOPATHY
Asahi Kasei Pharma America Corporation0 个研究点目标入组 800 人开始时间: 2012年10月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
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
入选标准
- •1. Subject must be receiving treatment in an ICU, or in an acute care setting (e.g., ER, Recovery Room) with documented orders to transfer to the ICU.
- •2. Subjects who have clinical evidence of bacterial infection and a known site of infection* (with or without confirmation by culture) and all of the following:
- •a. Currently receiving treatment with antibiotics.
- •b. WBC >12,000/mm3 or < 4,000/mm3 or Bandemia >10%.
- •c. Platelet counts in the range of > 30,000/mm3 to < 150,000/mm3
- •d. Fever with core temperature of <36ºC or >38ºC (If the subject received an antipyretic agent within 24 hours prior to screening, there must be a documented temperature of greater than 38ºC within 24 hours prior to administration of the antipyretic agent in order to still qualify for study participation.Axillary temperatures will not be acceptable.
- •Note; the presence of concurrent fungal or viral infection is allowed provided that the primary reason for treatment is bacterial infection.
- •3. Subjects with inflammatory changes due to sepsis defined by at least one of the following:
- •I. Cardiovascular Dysfunction defined as receiving vasopressors **to maintain Mean Arterial Pressure (MAP) greater than (>)65 mmHg for adequate tissue perfusion after adequate fluid resuscitation, where adequate fluid resuscitation is defined as:
- •a. Intravenous administration of 20 mL/kg crystalloid or 10 mL/kg colloid infusion for up to but no more than 6 hours OR
- •b. Adequate right atrial filling pressure if measured by Central Venous Pressure (CVP) of greater than (>) 8 mm Hg or Pulmonary Artery Wedge Pressure (PAWP) of greater than (>) 12 mm Hg.
- •* Appendix C, section 15.3
- •**If dopamine is the only vasopressor used, the infusion rate must be greater than (>) 5 ?g/kg/min (i.e. must be prescribed to support cardio-pulmonary perfusion).
- •II. Respiratory Failure is defined as the acute need for mechanical ventilation and PaO2/FiO2 ratio is <250 mmHg (or < 200 mmHg when lung is the site of infection). For the purpose(s) of this protocol, mechanical ventilation is defined as any type of ventilation administered via an endotracheal tube or nasotracheal intubation. This applies to all modes of mechanical ventilation such as Volume Assist (VA), Volume Control (VC) or Pressure Control (PC). Pressure Support Ventilation(PSV) is permissible. A simple administration of supplemental oxygen is NOT considered as mechanical ventilation for the purposes of this study.
- •4. Subjects with coagulopathy characterized by an INR >1.40 without other known etiology (e.g., anticoagulant therapy).
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1. Subject or Authorized Representative is unable to provide informed consent (as applicable per local and country regulations)
- •2. Subject is pregnant or breastfeeding or intends to get pregnant within 28 days of enrolling into the study
- •3. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital
- •4. Subject is < 18 years of age
- •5. Subject has a known allergy to ART-123 or any components of the drug product
- •6. Subject is unwilling to allow transfusion of blood or blood products
- •7. Presence of an advance directive to withhold life-sustaining treatment including Cardiopulmonary Resuscitation (CPR).
- •8. Subject has had previous treatment with ART-123
- •9. Body weight >= 175 kg
- •10. PT prolongation or thrombocytopenia that is not due to sepsis (e.g. AML or ALL in induction therapy, acute leukemia of the M3 type, myeloablative therapy within 4 weeks prior to enrollment, AIDS with persistent thrombocytopenia and/or bleeding disorder, pre-existing thrombocytopenia or coagulopathy)
- •11. Intra-thoracic or intra-abdominal surgery within the 12 hours prior to consent, or ongoing impairment of hemostasis as a result of one of these procedures
- •12. A history of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding within 3 months prior to consent (subjects with minor head trauma may be enrolled if there is a normal neurological examination and a normal CT scan of the head/spine post injury documented in the medical record)
- •13. Cerebral Vascular Accident (CVA) within 3 months prior to consent
- •14. Any history of Intracerebral Arteriovenous Malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system
- •15. A history of congenital bleeding diatheses (e.g. hemophilia)
- •16. Significant gastrointestinal bleeding (e.g., melena, hematemesis) within 6 weeks prior to consent unless a corrective interventional procedure has been performed (i.e. endoscopy)
- •17. Subject is diagnosed with a known medical condition associated with a hypercoagulable state, including:
- •a. Resistance to activated protein C or known Factor V Leiden
- •b. Hereditary deficiency of protein C or protein S
- •c. Presence of anticardiolipin antibody, antiphospholipid antibody, or
- •prothrombin gene mutation
- •d. Deep-vein thrombosis or pulmonary embolism within 3 months prior to consent (if evaluation is in progress, this should be completed before consideration for this trial)
- •e.Any disorder with a requirement for full anticoagulation
- •18. Child-Pugh score of 10-15 (Class C)
- •19. Portosystemic hypertension or known history of bleeding esophageal varices
- •20. History of solid organ, allogeneic bone marrow, or stem cell transplantation within the 6 months prior to consent (uncomplicated kidney and autologous stem cell/bone marrow transplant subjects may be enrolled at any time after they have recovered from their transplant procedure)
- •21. Acute pancreatitis where infection has not been documented by a positive blood or abdominal fluid culture. Also, in the opinion of the tre
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