EUCTR2014-000899-25-LT进行中（未招募）1 期
A Phase II Double-blind, Randomised, Parallel Group 2:1 Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human Interferon Beta-1a) and Placebo in the Prevention of Multi-Organ Failure on Patients Surviving Open Surgery for a Ruptured Abdominal Aortic Aneurysm - INFORAAA study
Faron Pharmaceuticals Ltd0 个研究点目标入组 152 人开始时间: 2017年5月16日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 152
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
- •To be eligible for inclusion into this study, each patient must fulfil the following inclusion criteria during screening and prior to the first dose of study medication being administered on D0 (criteria 1 or 2 and all 3, 4 and 5):
- •1. Patients (male or female) presenting with a ruptured abdominal aortic aneurysm (RAAA) diagnosed by ultrasound or CT-scan in the emergency room
- •all forms of infrarenal RAAAs with or without coexisting iliac aneurysms are included
- •2. Patients (male or female) presenting with symptoms of RAAA known to have an infrarenal AAA and proceeding straight to open repair without radiological assessment and confirmed rupture (=retroperitoneal haematoma) in operation
- •3. Aneurysma repair must be infra-renal, i.e. the proximal anastomosis must be below the renal arteries and the renal arteries have to stay intact. Temporary above the renal clamping can be used for a maximum of 30 minutes (total clamping time)
- •4. Patients or their next of kin providing informed consent (written signed or witnessed)
- •5. Age of 18 years or higher
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 137
排除标准
- •To be eligible for inclusion into this study, each patient must not meet any of the following exclusion criteria during screening or prior to the first dose of study medication being administered:
- •1. Moribund patient not eligible for treatment in ICU or expected to survive surgery
- •2. Markedly short life expectancy, e.g. advanced malignant disease
- •3. Current participation in another experimental treatment protocol
- •4. Significant congestive heart failure, defined as New York Heart Association (NYHA) class IV
- •5. Current treatment with IFN alpha or IFN beta
- •6. Dialysis therapy for chronic renal failure
- •7. Irreversible shock from haemorrhage
- •8. Unconsciousness when arriving to the hospital and during screening
- •9. rEVAR first (prior attempt for endovascular aortic repair for the current rupture)
- •10. Diagnosed cirrhosis
- •11. Pregnancy and women with child bearing potential without negative pregnancy test
- •12. Rupture not confirmed by CT or intra-operatively (impending ruptures are excluded)
- •13. RAAA requiring repair of the renal arteries or the proximal aorta
- •thoracoabdominal aneurysms requiring immediate repair
- •damaged renal arteries during emergency clamping requiring repair
- •temporary clamping above the renal arteries (max 30 min total clamping time above the renal arteries) does not lead to exclusion
- •ligation of the left renal vein does not lead to exclusion
研究者
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