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

August 13, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5760

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult patients hospitalized in intensive care for ≥2 days

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
evaluate the impact of multifaceted support for STOP-A implementation on hospital mortality, taking into account the stepped wedge design structure.
Time Frame: Day 0 to Day 90
in-hospital mortality, up to day 90
Day 0 to Day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate the impact of implementation support on Hb levels
Time Frame: 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.
Time Frame: 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
Time Frame: 6 Months
all-cause mortality at 6 months
6 Months
Assess the impact of implementation support on survival
Time Frame: 6 months
6-month survival curves
6 months
Assess the impact of implementation support (STOP-A) on professional practices
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: Day 90
Day 90
Evaluate the impact of EPO treatment in patients with Hb<12 g/dL
Time Frame: Day 90
Day 90
Evaluate the impact of implementation support (STOP-A) on complications due to healthcare
Time Frame: 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
Time Frame: 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.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 49RC25_0386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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