EUCTR2014-002998-11-DK进行中（未招募）1 期
Safety and efficacy of low-dose Iloprost administration and blood pressure target in addition tostandard therapy, as compared to standard therapy alone, in post-cardiac-arrest-syndrome patients – a randomized, controlled, double-blindedinvestigator-initiated trial - ENDO-RCA
Rigshospitalet, Capital Region Bloodbank 2034, Section for Transfusion Medicine0 个研究点开始时间: 2014年9月23日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Age =18 years
- •2. OHCA of presumed cardiac cause
- •3. Sustained ROSC*
- •4. Unconsciousness (GCS <8) (patients not able to obey verbal
- •commands) after sustained ROSC
- •5. Target temperature management is indicated.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Conscious patients (obeying verbal commands)
- •2. Females of childbearing potential (unless a negative HCG test can rule
- •out pregnancy within the inclusion window)
- •3. In-hospital cardiac arrest (IHCA)
- •4. OHCA of presumed non-cardiac cause, e.g. after trauma or
- •dissection/rupture of major artery OR Cardiac arrest caused by initial
- •hypoxia (i.e. drowning, suffocation, hanging).
- •5. Known congenital bleeding diathesis (medically induced coagulopathy
- •due to treatment with Vitamin K antagonists, Thrombininhibitors, Factor
- •Xa inihbitors, ADP-receptor inhibitors, Aspirin, Asasantin, Persantin,
- •NSAID, unfractionated and low molecular weight heparin does NOT
- •exclude the patient).
- •6. Suspected or confirmed acute intracranial bleeding
- •7. Suspected or confirmed acute stroke
- •8. Unwitnessed asystole
- •9. Known limitations in therapy and Do Not Resuscitate-order
- •10. Known disease making 180 days survival unlikely
- •11. Known pre-arrest CPC 3 or 4
- •12. >4 hours (240 minutes) from ROSC to screening
- •13. Systolic blood pressure <80 mm Hg in spite of fluid
- •loading/vasopressor and/or inotropic medication/intra aortic balloon
- •pump/axial flow device*
- •14. Temperature on admission <30°C.
- •15. Known allergy to Prostacyclin analogues
研究者
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