EUCTR2006-002873-35-GB进行中（未招募）1 期
Exploratory efficacy and safety, pharmacokinetics and dose-finding study of ATryn® (antithrombin alfa) in patients with disseminated intravascular coagulation associated with severe sepsis
EO Pharmaceutical Products Ltd A/S (LEO Pharma A/S)0 个研究点目标入组 200 人开始时间: 2007年2月26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
- 200
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. Signed informed consent has been obtained from the patient or his/her legally acceptable representative
- •2. Severe sepsis defined as: a. Systemic inflammatory response syndrome (SIRS) related to the current sepsis episode with at least three of the following clinical findings: body temperature (rectal, ear or core) > 38°C or < 36°C; heart rate > 90 beats/minute; hyperventilation (evidenced by a respiratory rate of > 20 breaths/minute or a PaCO2 of < 32 mmHg) or mechanical ventilation; leucocyte count > 12000 cells/microlitre or < 4000 cells/microlitre (if a medical condition or medication prevents tachycardia, two SIRS criteria are acceptable) and b. Minimum one sustained organ failure (respiratory failure, renal dysfunction, hepatic dysfunction, or metabolic acidosis or septic shock) and c. Clinical signs of infection caused by a bacterial or fungal pathogen
- •3. Disseminated intravascular coagulation (>= 5 points on overt or non overt DIC score)
- •4. Maximum time from diagnosis of first organ failure to randomisation: 48 hours. Maximum time from diagnosis of DIC to randomisation: 24 hours.
- •5. At least 18 years of age
- •6. Males or non-pregnant females. Females of child bearing potential should have a negative urine or serum pregnancy test within 24 hours prior to drug administration
- •7. Any ethnic origin
- •8. Patient hospitalised at an intensive care unit (ICU)
- •9. At the time of enrolment there has to be intent by physicians and families to aggressively treat the patient
- •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. Previous treatment with an antithrombin concentrate or recombinant human activated protein C (rhAPC) within the current sepsis episode
- •2. Treatment with unfractionated heparin (UFH) or low molecular weight heparin (LMWH) at any dose within the last 6 or 18 hours before randomisation, respectively
- •3. Anticipated need for treatment with UFH/LMWH, pentasaccharide (e.g. fondaparinux), oral anticoagulants or thrombolytic agents during 6 days post randomisation (e.g. current VTE, atrial fibrillation, ongoing VTE prophylaxis or hypercoagulable state)
- •4. Intended treatment with rhAPC during 6 days post randomisation
- •5. Treatment with oral anticoagulants within the last 48 hours before randomisation and INR above 1.5
- •6. Treatment with: clopidogrel, glycoprotein IIb/IIIa inhibitors or acetylsalicylic acid at doses >325 mg/day within 5 days prior to randomisation
- •7. Anticoagulant treatment with pentasaccharide (e.g. fondaparinux) within 7 days prior to randomisation
- •8. Conditions other than sepsis anticipated to be terminal within 6 months
- •9. Known bleeding disorder other than DIC
- •10. Chronic vegetative state
- •11. Incurable malignancy with documented metastases
- •12. Haematological neoplasia where cytostatic treatment has been administered within two months prior to randomisation
- •13. Bone marrow aplasia or treatment induced low platelet count (due to immunosuppressive medication)
- •14. Preexisting dialysis-dependent renal failure
- •15. Known advanced chronic liver disease corresponding to Child-Pugh class C (measured prior to ICU admission outside the current sepsis episode) or any history of bleeding from oesophageal varices
- •16. Overt, ongoing serious haemorrhage
- •17. Advanced directive to withhold life-supporting treatment (except cardiopulmonary resuscitation)
- •18. Major burns involving > 20% of the body surface
- •19. Platelet count < 20000/microlitre (patients should not be included if they require a platelet transfusion to bring their platelet level above 20000/microlitre just prior to randomisation)
- •20. Acute Myocardial Infarction within 7 days prior to randomisation. Please note that troponin levels may be elevated due to sepsis
- •21. Recent (within 30 days prior to randomisation) or planned (during 6 days post randomisation) heart surgery with cardio-pulmonary bypass
- •22. Transplantation within 30 days prior to randomisation
- •23. History of stroke within the last 90 days prior to randomisation
- •24. Severe cranial or spinal trauma within the last 90 days before randomisation or known cranial or spinal space occupying lesion, intracerebral arteriovenous malformation or cerebral aneurysm
- •25. Epidural catheter within 12 hours before randomisation or planned epidural catheter during 6 days post randomisation
- •26. Recent (within 30 days prior to randomisation) or planned (during 6 days post randomisation) cranial or spinal surgery (except nontraumatic lumbar puncture)
- •27. Any major surgery with increased high risk of bleeding within 12-hours before randomisation or planned major surgery with increased high risk of bleeding during 6 days post randomisation (except tracheostomy)
- •28. Trauma patients with increased risk of bleeding e.g. significant contusion to lung, liver or spleen, retroperitoneal bleed, pelvic fracture or compartment syndrome within 48 hour before randomisation
- •29. Known or suspected hypersensitivity to component(s) of investigational products or known or suspected hypersensitivity to goats or goat products
- •30. Current participation in any ot
研究者
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