EUCTR2006-002112-99-ES进行中（未招募）1 期
A Phase 2 Study to Evaluate Dose and Duration of Treatment of Drotrecogin Alfa (Activated) Using Serial Measurements of Protein C in Patients with Severe Sepsis and Multiple Organ Dysfunction - RESPOND
illy S.A0 个研究点目标入组 488 人开始时间: 2012年3月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 488
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] Adult patients (?18 years old) with severe sepsis and multiple organ
- •dysfunction.
- •Patients with severe sepsis are defined by the following criteria. Both criteria must be
- •met for a diagnosis of severe sepsis with multiple organ dysfunction.
- •? Presence of a suspected or proven infection. Patients with a suspected
- •infection must have evidence of an infection, such as white blood cells in a
- •normally sterile body fluid, perforated viscus, chest x-ray consistent with
- •pneumonia and associated with purulent sputum production, or a clinical
- •syndrome associated with a high probability of infection, for example,
- •purpura fulminans or ascending cholangitis.
- •? Presence of multiple organ dysfunction, which is defined as two or more
- •sepsis-associated organ dysfunctions defined below.
- •Note: A patient must have organ dysfunctions attributable to the sepsis
- •episode. The organ dysfunctions must be newly developed and not
- •explained by underlying disease processes or by the effects of concomitant
- •therapy. A non-sepsis-induced organ dysfunction may not be used to
- •qualify the patient for the study even if the organ dysfunction worsens as a
- •result of the sepsis episode.
- •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 244
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 244
排除标准
- •2] Have documented multiple organ dysfunction for greater than 24 hours
- •prior to the start of study drug or the first documented sepsis-induced
- •organ dysfunction occurred greater than 36 hours prior to the start of
- •study drug.
- •[3] Weigh less than 30 kg or greater than 135 kg.
- •[4] Have a platelet count <30,000/mm3.
- •[5] Patients with active internal bleeding or at increased risk for bleeding,
- •for example:
- •(a) Any major surgery, defined as surgery that requires general or
- •spinal anesthesia, performed within the 12-hour period
- •immediately preceding the drotrecogin alfa (activated) infusion,
- •or any postoperative patient who demonstrates evidence of active
- •bleeding, or any patient with planned or anticipated surgery
- •during the infusion period
- •(b) Biopsy or surgical procedure of a closed-space within the
- •12 hours immediately preceding the drotrecogin alfa (activated)
- •infusion where there is a high risk of significant bleeding and
- •where it would not be possible to control bleeding by external
- •(c) History (within the previous 3 months) of stroke or severe head
- •trauma that required hospitalization or intracranial surgery.
- •(d) History of intracranial arteriovenous malformation, cerebral
- •aneurysm, or central nervous system mass lesion.
- •(e) Patients with an epidural catheter or who are anticipated to
- •receive an epidural catheter during drotrecogin alfa (activated)
- •(f) History of congenital bleeding diatheses (for example,
- •hemophilia).
- •(g) Gastrointestinal bleeding within the 6 weeks prior to study entry
- •that required medical intervention unless definitive endoscopic
- •procedure or surgery has been performed.
- •(h) Trauma patients at increased risk of bleeding (for example, flail
- •chest; significant contusion to lung, liver, or spleen;
- •retroperitoneal bleed; pelvic fracture; compartment syndrome).
- •(i) Patients with known esophageal varices, chronic jaundice,
- •cirrhosis, or chronic ascites.
- •[6] Have a concurrent need for any of the following medications during
- •the drotrecogin alfa (activated) infusion:
- •(a) Therapeutic heparin, defined as unfractionated heparin
- •>15,000 units/day within 8 hours of study entry or low molecular
- •weight heparin used at any dose higher or more frequent than the
- •recommended dose in the product label for prophylaxis within
- •12 hours of study entry.
- •(b) Warfarin, if used within 7 days of study entry or warfarin-type
- •medications within <5 half-lives at the time of study entry and
- •where the prothrombin time (PT) is prolonged beyond the upper
- •limit of normal for the institution.
- •(c) Antiplatelets such as ticlopidine, clopidogrel, or acetylsalicylic
- •acid (ASA) >650 mg/day or compounds that contain ASA
- •>650 mg/day within 3 days prior to study entry.
- •(d) Thrombolytic therapy (unless used to treat an intra-catheter
- •thrombosis; however, care should be taken to avoid systemic
- 另有 11 项未显示
研究者
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