Improved Recovery by Iron following Surgery with blood loss, a double-blind multi-centre randomized controlled phase III drug trial (the IRIS-trial)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 338
- 试验地点
- 5
- 主要终点
- To examine if 1000 mg iv Ferric Carboxymaltose administered immediately following hepatic or pancreatic resection or complex aortic surgery with 400 – 4000 ml perioperative blood loss affect a composite of death, number of red blood cells transfusions, post-operative severe anaemia (Hb < 80 g/L) and change in FACT-An QoL compared to pre-operative baseline at five weeks after surgery. The composite endpoint is assessed by win ratio in the order given above.
研究概览
简要总结
To examine if 1000 mg iv Ferric Carboxymaltose administered immediately following hepatic or pancreatic resection or complex aortic surgery with 400 – 4000 ml perioperative blood loss affect a composite of death, number of red blood cells transfusions, post-operative severe anaemia (Hb < 80 g/L) and change in quality of life five weeks post operatively using FACT-An QoL questionnaire
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent
- •Male and female participants
- •Weight > 50 kg
- •> 18 years of age
- •Scheduled for complex aortic surgery, liver resection or pancreatic resection
排除标准
- •Short expected survival (less than six months)
- •Unsuitable for inclusion according to the investigator
- •Pregnancy or breastfeeding
- •Intra-venous iron therapy within one month prior to surgery
- •Severe anaemia (B-Hb <80 mg/L) prior to surgery
- •Contraindication to Ferric Carboxymaltose according to SmPC
- •Iron overloading disorder, i.e. hemochromatosis
- •Risk of small for size future liver remnant
- •Pre-operative renal replacement therapy
- •Enrolled in another drug or medical device study within 30 days prior to enrolment of the current study
- •Another planned major surgical procedure before the five week follow up
研究组 & 干预措施
-
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
To examine if 1000 mg iv Ferric Carboxymaltose administered immediately following hepatic or pancreatic resection or complex aortic surgery with 400 – 4000 ml perioperative blood loss affect a composite of death, number of red blood cells transfusions, post-operative severe anaemia (Hb < 80 g/L) and change in FACT-An QoL compared to pre-operative baseline at five weeks after surgery. The composite endpoint is assessed by win ratio in the order given above.
To examine if 1000 mg iv Ferric Carboxymaltose administered immediately following hepatic or pancreatic resection or complex aortic surgery with 400 – 4000 ml perioperative blood loss affect a composite of death, number of red blood cells transfusions, post-operative severe anaemia (Hb < 80 g/L) and change in FACT-An QoL compared to pre-operative baseline at five weeks after surgery. The composite endpoint is assessed by win ratio in the order given above.
次要结局
- If the intervention affects levels of post operative Hb, and if this is linked to the primary outcome and affects early post operative recovery and performance status five weeks after surgery.
- If the intervention affects complication rate after surgery, re-admissions to hospital after discharge and re-interventions after primary surgery. Analysed 1 year after surgery.
- If the intervention affects chance of receiving systemic oncological therapy in case of malignant disease. Follow-up 1 year after surgery.
- If the intervention affects rate of spinal ischemia after complex aortic repair. Follow-up 1 year after surgery.
- Effects of Ferric Carboxymaltose between 5 weeks to 5 years after surgery in different subgroups.
- Number of adverse events reported during administration of Ferric Carboxymaltose iv and during the 5-week follow-up after surgery.
- Morbidity, mortality and recurrence of oncological disease reported during the 5-year follow-up.
研究者
Department of Surgery, Jon Unosson
Scientific
Region Uppsala