EUCTR2006-002873-35-FR进行中（未招募）不适用
Exploratory efficacy and safety, pharmacokinetics and dose-finding study of ATryn® (antithrombin alfa) in patients with disseminated intravascular coagulation associated with severe sepsis
EO Pharma A/S0 个研究点目标入组 200 人开始时间: 2007年3月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 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) 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/mgl or < 4000 cells/mgl
- •and b. Minimum two organ failures (respiratory failure, renal dysfunction, hepatic dysfunction, or metabolic acidosis) or refractory 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. Predicted mortality between 30 and 60% (43 to 56 points on Simplified Acute Physiology Score II (SAPS II))
- •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. Maximum time from diagnosis of first organ failure to randomisation: 48 hours. Maximum time from diagnosis of second organ failure or septic shock to randomisation: 24 hours.
- •10. 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 or currently indicated
- •6. Anticoagulant treatment with pentasaccharide (e.g. fondaparinux) within 7 days prior to randomisation or currently indicated
- •7. Conditions other than sepsis anticipated to be terminal within 6 months
- •8. Known bleeding disorder other than DIC
- •9. Chronic vegetative state
- •10. Incurable malignancy with documented metastases
- •11. Haematological neoplasia during cytostatic treatment
- •12. Bone marrow aplasia
- •13. Preexisting dialysis-dependent renal failure
- •14. Known advanced chronic liver disease corresponding to Child-Pugh class B or C (measured prior to ICU admission outside the current sepsis episode) or any history of bleeding from oesophagus varices
- •15. Overt, ongoing serious haemorrhage
- •16. Advanced directive to withhold life-supporting treatment (except cardiopulmonary resuscitation)
- •17. Major burns involving > 20% of the body surface
- •18. Platelet count < 30000/mgl (unsupported)
- •19. Acute Myocardial Infarction within 7 days prior to randomisation having led to cardiogenic shock
- •20. Recent (within 30 days prior to randomisation) or planned (during 6 days post randomisation) heart surgery with cardio-pulmonary bypass
- •21. Transplantation within 30 days prior to randomisation
- •22. History of stroke within the last 90 days prior to randomisation
- •23. Severe cranial or spinal trauma within the last 90 days before randomisation or known cranial or spinal space occupying lesion
- •24. Recent (within 30 days prior to randomisation) or planned (during 6 days post randomisation) cranial or spinal surgery (except nontraumatic lumbar puncture)
- •25. Planned major surgery during 6 days post randomisation except tracheostomy
- •26. Known or suspected hypersensitivity to component(s) of investigational products or known or suspected hypersensitivity to goats or goat products
- •27. Current participation in any other interventional clinical trial .
- •28. Patients who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 30 days prior to randomisation
- •29. Previously enrolled in this trial
研究者
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