临床试验/2024-515920-35-01

2024-515920-35-01招募中4 期

Intravenous iron to treat postoperative anaemia in older cardiac surgery patients: a randomized controlled trial (AGE ANAEMIA study)

Sint Antonius Ziekenhuis Stichting4 个研究点分布在 1 个国家目标入组 310 人开始时间: 2024年8月22日最近更新: 2024年8月22日

试验速览

阶段: 4 期
状态: 招募中
发起方: Sint Antonius Ziekenhuis Stichting
入组人数: 310
试验地点: 4
主要终点: Primary endpoint is disability as measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12) at POD 90 after elective cardiac surgery.

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine the effect of treatment of of postoperative iron deficiency anaemia with intravenous iron on disability at 90 days after cardiac surgery

入排标准

年龄范围: 65 years 至 65+ years（65+ Years）
接受健康志愿者: 否

入选标准

• Mentally competent with age ≥ 70 years  Elective AVR or CABG surgery (including AVR or CABG surgery combined with rhythm surgery, i.e. maze, pulmonary vein isolation and left auricular ear amputation)  Expected uncomplicated postoperative trajectory, defined as: - No inotropic agents or ventilation at time of final inclusion (POD 1) - Expected discharge to general ward at POD 1  Moderate postoperative IDA, defined as: - Hb between 85 and 110 g/L and - Ferritin <100 μg/L or - Iron saturation (TSAT) < 20%

排除标准

• Medical history of iron overload/haemochromatosis  Medical history of liver cirrhosis or ALT/AST value in blood serum triple of normal value (female patients: ALT >120, AST >105 U/L. Male patients: ALT>150, AST>135 U/L)  Severe renal failure (eGFR<15ml/min/1.73m2)  Recent treatment with IVI (<12 weeks prior)  Serious or severe allergic reaction to IVI in medical history  Severe asthma or eczema in medical history (atopic constitution)

结局指标

主要结局

Primary endpoint is disability as measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12) at POD 90 after elective cardiac surgery.

次要结局

Postoperative RBC transfusions; Change in reticulocyte hemoglobin content from randomization to hospital discharge; Hb levels at hospital discharge; Hospital complications according to the Nederlandse Hart Registratie (NHR); Days alive and out of hospital at POD 90; Change in PROMs regarding dyspnoea symptoms at POD 90 (assessed with the RDS)

研究者

发起方

Sint Antonius Ziekenhuis Stichting

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Thomas van Dijk

Scientific

Sint Antonius Ziekenhuis Stichting

研究点 (4)

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