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Study Evaluating Multifaceted Support for the Implementation of Recommendations for the Prevention and Management of Anemia in Intensive Care Units (STOP-A)

2026年8月13日 更新者：University Hospital, Angers

STOP-A _ Multicenter, Prospective, Randomized, Stepped-wedge Study Evaluating Multifaceted Support for the Implementation of Recommendations for the Prevention and Management of Anemia in Intensive Care Units

STOP-A is a prospective, multicenter data study aimed at demonstrating the impact of multifaceted support for the implementation of recommendations on the prevention and management of anemia in intensive care, compared to previous practices, on hospital mortality in adult patients hospitalized in intensive care for ≥2 days. The timing of implementation in each center is determined randomly by stepped-wedge randomization.

As such, this is a pragmatic study that meets the international PRECIS-2 criteria.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

5760

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 法国
      • Angers、法国、49000
        • réanimation médicale CHU ANGERS
        • 接触：
      • Argenteuil、法国
      • Brest、法国
        • CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation chirurgicale
        • 接触：
      • Brest、法国
        • CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation médicale
        • 接触：
      • Chartres、法国
        • Ch Chartres Louis Pasteur-Le Coudray
        • 接触：
      • Cholet、法国
      • Clermont-Ferrand、法国
        • HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Médico-Chrirugicale
        • 接触：
      • Clermont-Ferrand、法国
        • HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Neurochirurgicale
        • 接触：
      • Grenoble、法国
        • CHU Grenoble-HOPITAL SUD - CHU38
        • 接触：
      • Laval、法国
      • Le Mans、法国
        • Centre Hospitalier du Mans
        • 接触：
      • Montpellier、法国
        • Hopital St Eloi Chu Montpellier
        • 接触：
      • Nancy、法国
        • Chru Nancy - Hopitaux de Brabois
        • 接触：
      • Nantes、法国
      • Nantes、法国
      • Paris、法国
        • Gcs Irm Beaujon Moleculaire Act, Ap-Hp
        • 接触：
      • Paris、法国
        • Hopital Cochin Tarnier Aphp
        • 接触：
      • Paris、法国
        • Hu Est Parisien Site St Antoine Aphp
        • 接触：
      • Paris、法国
        • Hu Paris Nord Site Bichat Aphp
        • 接触：
      • Paris、法国
        • HU PITIE SALPETRIERE APHP, Réanimation Chirurgicale
        • 接触：
      • Paris、法国
        • HU PITIE SALPETRIERE APHP, Réanimation Neuro-Chirurgicale
        • 接触：
      • Poitiers、法国
      • Rennes、法国
      • Strasbourg、法国
      • Talence、法国
      • Toulouse、法国
      • Tours、法国
        • Chru Trousseau - Chambray
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

adult patients hospitalized in intensive care for ≥2 days

描述

Inclusion Criteria:

  • Length of stay in intensive care is ≥ 2 days
  • The patient has at least one organ failure lasting 24 hours or more (catecholamine infusion and/or mechanical ventilation (invasive or NIV > 6 hours/day))
  • No objection to data collection (patient or relative)

Exclusion Criteria:

  • Terminally ill patient with limited active treatment options within 72 hours of admission.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
evaluate the impact of multifaceted support for STOP-A implementation on hospital mortality, taking into account the stepped wedge design structure.
大体时间：Day 0 to Day 90
in-hospital mortality, up to day 90
Day 0 to Day 90

次要结果测量

结果测量
措施说明
大体时间
Evaluate the impact of implementation support on Hb levels
大体时间：hospital discharge or day 28
hemoglobin level in g/dl
hospital discharge or day 28
Assess the impact of implementation support on recovery after ICU discharge.
大体时间：Day 90
number of days living in the previous place of residence prior to D90
Day 90
Evaluate impact of implementation support on longer-term mortality
大体时间：6 Months
all-cause mortality at 6 months
6 Months
Assess the impact of implementation support on survival
大体时间：6 months
6-month survival curves
6 months
Assess the impact of implementation support (STOP-A) on professional practices
大体时间：From enrollment to the end of recruitment
RFE compliance rate (calculation of an RFE compliance index, IRR, comprising 6 items and scored out of 8 points) between the pre-implementation and post-implementation phases
From enrollment to the end of recruitment
Assess the impact of implementation support on transfusion use between the two phases.
大体时间：From enrollment to the end of recruitment
Rate of transfused patients relative to the number of hospitalized patients in each phase
From enrollment to the end of recruitment
Assess impact of implementation support on transfusion use between the two phases.
大体时间：From enrollment to the end of recruitment
transfusion index relative to the number of hospitalized patients in each phase
From enrollment to the end of recruitment
Assess the impact of implementation support on transfusion use between the two phases.
大体时间：From enrollment to the end of recruitment
the number of red blood cell units relative to the number of hospitalized patients
From enrollment to the end of recruitment
Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase
大体时间：day 90
The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed in subgroups of patients with an IRR >75% vs. <20%;
day 90
Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase
大体时间：day 90
The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed according to IRR quartiles.
day 90
Evaluate the impact of implementation support (STOP-A) in traumatized and non-traumatized patients.
大体时间：Day 90
Day 90
Evaluate the impact of EPO treatment in patients with Hb<12 g/dL
大体时间：Day 90
Day 90
Evaluate the impact of implementation support (STOP-A) on complications due to healthcare
大体时间：hospital discharge or day 28
thromboembolic events occurring in intensive care
hospital discharge or day 28
Evaluate the impact of implementation support (STOP-A) on complications due to healthcare
大体时间：hospital discharge or day 28
transfusion-related adverse events
hospital discharge or day 28
Evaluate the efficiency of assistance in implementing RFEs (STOP-A) through a cost-effectiveness analysis.
大体时间：day 180
Differential cost-effectiveness ratio, expressed as cost per life year gained at 3 and 6 months after admission to intensive care, from the perspective of the French healthcare system and from the hospital perspective.
day 180

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Angers

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2028年3月1日

研究注册日期

首次提交

2026年7月30日

首先提交符合 QC 标准的

2026年8月13日

首次发布 (实际的)

2026年8月18日

研究记录更新

最后更新发布 (实际的)

2026年8月18日

上次提交的符合 QC 标准的更新

2026年8月13日

最后验证

2025年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 49RC25_0386

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.

IPD 共享时间框架

The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.

IPD 共享访问标准

The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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