Study Evaluating Multifaceted Support for the Implementation of Recommendations for the Prevention and Management of Anemia in Intensive Care Units
STOP-A
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
1 other identifier
observational
5,760
1 country
27
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2026
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2026
CompletedFirst Posted
Study publicly available on registry
August 18, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
August 18, 2026
October 1, 2025
1.3 years
July 30, 2026
August 13, 2026
Conditions
Outcome Measures
Primary Outcomes (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
Day 0 to Day 90
Secondary Outcomes (15)
Evaluate the impact of implementation support on Hb levels
hospital discharge or day 28
Assess the impact of implementation support on recovery after ICU discharge.
Day 90
Evaluate impact of implementation support on longer-term mortality
6 Months
Assess the impact of implementation support on survival
6 months
Assess the impact of implementation support (STOP-A) on professional practices
From enrollment to the end of recruitment
- +10 more secondary outcomes
Interventions
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.
Eligibility Criteria
adult patients hospitalized in intensive care for ≥2 days
You may qualify if:
- 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)
You may not qualify if:
- Terminally ill patient with limited active treatment options within 72 hours of admission.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
réanimation médicale CHU ANGERS
Angers, 49000, France
Ch Victor Dupouy
Argenteuil, France
CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation chirurgicale
Brest, France
CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation médicale
Brest, France
Ch Chartres Louis Pasteur-Le Coudray
Chartres, France
Ch de Cholet
Cholet, France
HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Médico-Chrirugicale
Clermont-Ferrand, France
HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Neurochirurgicale
Clermont-Ferrand, France
CHU Grenoble-HOPITAL SUD - CHU38
Grenoble, France
CH de LAVAL
Laval, France
Centre Hospitalier Du Mans
Le Mans, France
Hopital St Eloi Chu Montpellier
Montpellier, France
Chru Nancy - Hopitaux de Brabois
Nancy, France
Hopital Laenec, CHU Nantes
Nantes, France
Hôtel Dieu, CHU Nantes
Nantes, France
Gcs Irm Beaujon Moleculaire Act, Ap-Hp
Paris, France
Hopital Cochin Tarnier Aphp
Paris, France
Hu Est Parisien Site St Antoine Aphp
Paris, France
Hu Paris Nord Site Bichat Aphp
Paris, France
HU PITIE SALPETRIERE APHP, Réanimation Chirurgicale
Paris, France
HU PITIE SALPETRIERE APHP, Réanimation Neuro-Chirurgicale
Paris, France
CHU LA MILETRIE, réanimation neurochirurgicale
Poitiers, France
Chru Rennes Site Pontchaillou
Rennes, France
Hopital de Hautepierre
Strasbourg, France
Hopital Haut-Leveque - Chu
Talence, France
Hopital Purpan Chu Toulouse
Toulouse, France
Chru Trousseau - Chambray
Tours, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2026
First Posted
August 18, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
August 18, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
- Access Criteria
- The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
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.