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AnemiaSTOP-ANCT07771192

Study Evaluating Multifaceted Support for the Implementation of Recommendations for the Prevention and Management of Anemia in Intensive Care Units

An observational study of Anemia, run by University Hospital, Angers at 27 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
implementation of recommendations
How many people
5,760 participants
Where
27 sitesFrance
Study dates
1 Sep 2026to 1 Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: adult patients hospitalized in intensive care for ≥2 days

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sigismond LASOCKI, Professor contact

02 41 35 36 35

silasocki@chu-angers.fr

27 sites in 1 country

France27 sites

  • réanimation médicale CHU ANGERS

    Angers, 49000

    Pierre ASFAR, Professor, +33241355865, piasfar@chu-angers.fr

  • Ch Victor Dupouy

    Argenteuil

    Gaëtan PLANTEFEVE, Doctor, +33134233318, gaetan.plantefeve@ch-argenteuil.fr

  • CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation chirurgicale

    Brest

    Olivier LANGERON, Professor, +33298223333, olivier.langeron@chu-brest.fr

  • CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation médicale

    Brest

    Cécile AUBRON, Doctor, +33298223333, cecile.aubron@chu-brest.fr

  • Ch Chartres Louis Pasteur-Le Coudray

    Chartres

    Juliette AUDIBERT, Doctor, +33237303030, Jaudibert@ch-chartres.fr

  • Ch de Cholet

    Cholet

    Antony LEMEUR, Doctor, +33241496398, antony.lemeur@ch-cholet.fr

  • HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Médico-Chrirugicale

    Clermont-Ferrand

    Emmanuel FUTIER, Doctor, +33473750750, efutier@chu-clermontferrand.fr

  • HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Neurochirurgicale

    Clermont-Ferrand

    Russell CHABANNE, Doctor, +33473750750, rchabanne@chu-clermontferrand.fr

  • CHU Grenoble-HOPITAL SUD - CHU38

    Grenoble

    Pierre BOUZAT, Professor, +33476765295, PBouzat@chu-grenoble.fr

  • CH de LAVAL

    Laval

    Hussein YASSINE, +33 2 43 66 50 00, hussein.yassine@chlaval.fr

  • Centre Hospitalier Du Mans

    Le Mans

    Christophe GUITTON, Professor, +33243434343, cguitton@ch-lemans.fr

  • Hopital St Eloi Chu Montpellier

    Montpellier

    Samir JABER, Professor, +33467330262, s-jaber@chu-montpellier.fr

  • Chru Nancy - Hopitaux de Brabois

    Nancy

    Antoine KIMMOUN, Doctor, 383153030, akimmoun@gmail.com

  • Hopital Laenec, CHU Nantes

    Nantes

    Karim LAKHAL, Professor, +33240083333, Karim.LAKHAL@chu-nantes.fr

  • Hôtel Dieu, CHU Nantes

    Nantes

    ANTOINE ROQUILLY, Professor, +33253009191, Antoine.ROQUILLY@chu-nantes.fr

  • Gcs Irm Beaujon Moleculaire Act, Ap-Hp

    Paris

    Emmanuel WEISS, Professor, +33140874403, emmanuel.weiss@aphp.fr

  • Hopital Cochin Tarnier Aphp

    Paris

    Frederic PENE, Professor, +33158414141, frederic.pene@aphp.fr

  • Hu Est Parisien Site St Antoine Aphp

    Paris

    Franck VERDONK, Doctor, +33149282000, franck.verdonk@aphp.fr

  • Hu Paris Nord Site Bichat Aphp

    Paris

    Charles Philippe MONTRAVERS, Professor, +33140257910, philippe.montravers@aphp.fr

  • HU PITIE SALPETRIERE APHP, Réanimation Chirurgicale

    Paris

    Jean-Michel CONSTANTIN, Professor, +33142160000, jean-michel.constantin@aphp.fr

  • HU PITIE SALPETRIERE APHP, Réanimation Neuro-Chirurgicale

    Paris

    Vincent DEGOS, Professor, +33142160000, vincent.degos@inserm.fr

  • CHU LA MILETRIE, réanimation neurochirurgicale

    Poitiers

    Claire DAHYOT, Professor, +33549444230, Claire.DAHYOT-FIZELIER@chu-poitiers.fr

  • Chru Rennes Site Pontchaillou

    Rennes

    Yoann LAUNEY, Professor, +33299284321, yoann.launey@chu-rennes.fr

  • Hopital de Hautepierre

    Strasbourg

    Julien POTTECHER, Professor, +33388127066, julien.pottecher@chru-strasbourg.fr

  • Hopital Haut-Leveque - Chu

    Talence

    Olivier JOANNES-BOYAU, Doctor, +33556795679, olivier.joannes-boyau@chu-bordeaux.fr

  • Hopital Purpan Chu Toulouse

    Toulouse

    Thomas GEERAERTS, Professor, +33562746164, geeraerts.t@chu-toulouse.fr

  • Chru Trousseau - Chambray

    Tours

    Fabien ESPITALIER, Professor, +33247479040, f.espitalier@chu-tours.fr

Other trials in France

About this study

Official title: 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.

Conditions
Anemia
Being tested
implementation of recommendations
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • implementation of recommendationsOther

    The study will be organized into three periods:

    • a pre-implementation phase, with no changes to usual care;
    • a period of implementation of the recommendations;
    • a post-implementation phase.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. evaluate the impact of multifaceted support for STOP-A implementation on hospital mortality, taking into account the stepped wedge design structure.

    in-hospital mortality, up to day 90

    Measured: Day 0 to Day 90

Secondary outcomes (15)

  1. Evaluate the impact of implementation support on Hb levels

    hemoglobin level in g/dl

    Measured: hospital discharge or day 28

  2. Assess the impact of implementation support on recovery after ICU discharge.

    number of days living in the previous place of residence prior to D90

    Measured: Day 90

  3. Evaluate impact of implementation support on longer-term mortality

    all-cause mortality at 6 months

    Measured: 6 Months

  4. Assess the impact of implementation support on survival

    6-month survival curves

    Measured: 6 months

  5. Assess the impact of implementation support (STOP-A) on professional practices

    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

    Measured: From enrollment to the end of recruitment

  6. Assess the impact of implementation support on transfusion use between the two phases.

    Rate of transfused patients relative to the number of hospitalized patients in each phase

    Measured: From enrollment to the end of recruitment

  7. Assess impact of implementation support on transfusion use between the two phases.

    transfusion index relative to the number of hospitalized patients in each phase

    Measured: From enrollment to the end of recruitment

  8. Assess the impact of implementation support on transfusion use between the two phases.

    the number of red blood cell units relative to the number of hospitalized patients

    Measured: From enrollment to the end of recruitment

  9. Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase

    The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed in subgroups of patients with an IRR >75% vs. <20%;

    Measured: day 90

  10. Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase

    The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed according to IRR quartiles.

    Measured: day 90

  11. Evaluate the impact of implementation support (STOP-A) in traumatized and non-traumatized patients.

    Measured: Day 90

  12. Evaluate the impact of EPO treatment in patients with Hb<12 g/dL

    Measured: Day 90

  13. Evaluate the impact of implementation support (STOP-A) on complications due to healthcare

    thromboembolic events occurring in intensive care

    Measured: hospital discharge or day 28

  14. Evaluate the impact of implementation support (STOP-A) on complications due to healthcare

    transfusion-related adverse events

    Measured: hospital discharge or day 28

  15. Evaluate the efficiency of assistance in implementing RFEs (STOP-A) through a cost-effectiveness analysis.

    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.

    Measured: day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
5,760 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07771192
Sponsor's protocol ID
49RC25_0386
Acronym
STOP-A
Status last verified
Oct 2025
First submitted
30 Jul 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia, run by University Hospital, Angers at 27 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sigismond LASOCKI, Professor (02 41 35 36 35, silasocki@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07771192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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