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临床试验/NCT06637137
NCT06637137招募中不适用

Patient Blood Management in Cardiac Surgical Patients: the ICARUS-2 Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 464 人开始时间: 2025年2月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
464
试验地点
2
主要终点
Percentage of patients receiving RBC transfusion within post-operative day 7

研究概览

简要总结

The ICARUS 2 study has the general objective of collecting data in patients undergoing cardiac surgery; in our centre, in order to optimize and improve hemoglobin values, a team of haematologists, assisted by cardio anesthetists and cardiac surgeons, will evaluate the blood tests of patients scheduled for elective cardiac surgery in order to correct any states of hypoferritinemia (low iron in the blood) to promote recovery from blood losses related to cardiac surgery. This objective is strongly encouraged by the good use of blood programs currently in force at our foundation.

In particular, the research presented here intends to demonstrate a reduction in the number of intra- and post-operative transfusions.

详细描述

A significant percentage of patients schduled for cardiac surgery have an absolute or relative iron deficiency (ID) with or without anemia. Preoperative outpatient treatment of anemia and iron deficiency is one of the pillars of patient blood management (PBM). Data collected at our institution show that 35% of patients undergoing cardiac surgery at the Foundation receive 2 or more units of concentrated red blood cells at surgery or in the following 7 days. A recently published ambispective study (ICARUS) demonstrated that intravenous iron supplementation, even in the immediate pre-operative period (i.e 1 or 2 days), reduces the number of post-operative transfusions and the length of hospital stay. Similar results were recently obtained by other authors in a randomized study. Assuming the correction of ID at an earlier stage, the haematological outcome could be significantly better, with a reduction in the percentage of patients transfused and in the average transfusion requirement, increase in haemoglobin levels at discharge, improvement in clinical conditions and possible further reduction of the length of stay. All this could translate into a further reduction in costs related to the intervention.

The study is observational and involves the early application of the PBM program based on good clinical practice which includes the correction of absolute or relative ID. This deficiency will be treated at least 2 weeks before the planned cardiac surgery: the patient will receive an i.v. of iron in the clinic, in accordance with the indications, doses and route of administration for which the use of the drug is approved and the drug distributed on the market. At the same time as iron administration, vitamin supplementation will be prescribed (Vitamin B12 1 mg total subcutaneously) and oral folic acid (5 mg/day).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - all adult patients scheduled for elective cardiac surgery

排除标准

  • pregnancy
  • patient's refusal

研究组 & 干预措施

Prospectic cohort

patients scheduled for cardiac surgery who fulfil the inclusion criteria

干预措施: Iron (Drug)

retrospective cohort ICARUS 1

patients scheduled for cardiac surgery (2021) with a known iron status, treated if indicated 1 or 2 days before surgery with iron supplementation.

retrospective cohort

patients scheduled for cardiac surgery (2019-2020)with an unknown iron status and never treated with iron supplementation

结局指标

主要结局

Percentage of patients receiving RBC transfusion within post-operative day 7

时间窗: within post operative day 7

number of RBC units transfused from the operating room till post operative day 7

次要结局

  • cost measured in euros for the IDA treatment and blood product consumption(from enrollment to 1 week after surgery)
  • Hb values at last postoperative control within 7 days from surgery(within post operative day 7)
  • ICU lenght of stay(through study completion, an average of 2 year)
  • Number of allogenic blood products administered(within the first 7 days post operative)
  • mortality(from surgery within post operative day 7)
  • Hospital Lenght of Stay(through study completion, an average of 2 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

CORSI FILIPPO

Meidcal doctor, principal investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (2)

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