Study Evaluating Multifaceted Support for the Implementation of Recommendations for the Prevention and Management of Anemia in Intensive Care Units (STOP-A)
13. august 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
5760
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Sigismond LASOCKI, Professor
- Telefonnummer: 02 41 35 36 35
- E-mail: silasocki@chu-angers.fr
Studiesteder
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Angers, Frankrig, 49000
- réanimation médicale CHU ANGERS
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Kontakt:
- Pierre ASFAR, Professor
- Telefonnummer: +33241355865
- E-mail: piasfar@chu-angers.fr
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Argenteuil, Frankrig
- Ch Victor Dupouy
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Kontakt:
- Gaëtan PLANTEFEVE, Doctor
- Telefonnummer: +33134233318
- E-mail: gaetan.plantefeve@ch-argenteuil.fr
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Brest, Frankrig
- CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation chirurgicale
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Kontakt:
- Olivier LANGERON, Professor
- Telefonnummer: +33298223333
- E-mail: olivier.langeron@chu-brest.fr
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Brest, Frankrig
- CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation médicale
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Kontakt:
- Cécile AUBRON, Doctor
- Telefonnummer: +33298223333
- E-mail: cecile.aubron@chu-brest.fr
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Chartres, Frankrig
- Ch Chartres Louis Pasteur-Le Coudray
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Kontakt:
- Juliette AUDIBERT, Doctor
- Telefonnummer: +33237303030
- E-mail: Jaudibert@ch-chartres.fr
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Cholet, Frankrig
- CH de Cholet
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Kontakt:
- Antony LEMEUR, Doctor
- Telefonnummer: +33241496398
- E-mail: antony.lemeur@ch-cholet.fr
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Clermont-Ferrand, Frankrig
- HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Médico-Chrirugicale
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Kontakt:
- Emmanuel FUTIER, Doctor
- Telefonnummer: +33473750750
- E-mail: efutier@chu-clermontferrand.fr
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Clermont-Ferrand, Frankrig
- HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Neurochirurgicale
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Kontakt:
- Russell CHABANNE, Doctor
- Telefonnummer: +33473750750
- E-mail: rchabanne@chu-clermontferrand.fr
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Grenoble, Frankrig
- CHU Grenoble-HOPITAL SUD - CHU38
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Kontakt:
- Pierre BOUZAT, Professor
- Telefonnummer: +33476765295
- E-mail: PBouzat@chu-grenoble.fr
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Laval, Frankrig
- CH de LAVAL
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Kontakt:
- Hussein YASSINE
- Telefonnummer: +33 2 43 66 50 00
- E-mail: hussein.yassine@chlaval.fr
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Le Mans, Frankrig
- Centre Hospitalier du Mans
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Kontakt:
- Christophe GUITTON, Professor
- Telefonnummer: +33243434343
- E-mail: cguitton@ch-lemans.fr
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Montpellier, Frankrig
- Hopital St Eloi Chu Montpellier
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Kontakt:
- Samir JABER, Professor
- Telefonnummer: +33467330262
- E-mail: s-jaber@chu-montpellier.fr
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Nancy, Frankrig
- Chru Nancy - Hopitaux de Brabois
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Kontakt:
- Antoine KIMMOUN, Doctor
- Telefonnummer: 383153030
- E-mail: akimmoun@gmail.com
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Nantes, Frankrig
- Hopital Laenec, CHU Nantes
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Kontakt:
- Karim LAKHAL, Professor
- Telefonnummer: +33240083333
- E-mail: Karim.LAKHAL@chu-nantes.fr
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Nantes, Frankrig
- Hôtel Dieu, CHU Nantes
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Kontakt:
- ANTOINE ROQUILLY, Professor
- Telefonnummer: +33253009191
- E-mail: Antoine.ROQUILLY@chu-nantes.fr
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Paris, Frankrig
- Gcs Irm Beaujon Moleculaire Act, Ap-Hp
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Kontakt:
- Emmanuel WEISS, Professor
- Telefonnummer: +33140874403
- E-mail: emmanuel.weiss@aphp.fr
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Paris, Frankrig
- Hopital Cochin Tarnier Aphp
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Kontakt:
- Frederic PENE, Professor
- Telefonnummer: +33158414141
- E-mail: frederic.pene@aphp.fr
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Paris, Frankrig
- Hu Est Parisien Site St Antoine Aphp
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Kontakt:
- Franck VERDONK, Doctor
- Telefonnummer: +33149282000
- E-mail: franck.verdonk@aphp.fr
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Paris, Frankrig
- Hu Paris Nord Site Bichat Aphp
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Kontakt:
- Charles Philippe MONTRAVERS, Professor
- Telefonnummer: +33140257910
- E-mail: philippe.montravers@aphp.fr
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Paris, Frankrig
- HU PITIE SALPETRIERE APHP, Réanimation Chirurgicale
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Kontakt:
- Jean-Michel CONSTANTIN, Professor
- Telefonnummer: +33142160000
- E-mail: jean-michel.constantin@aphp.fr
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Paris, Frankrig
- HU PITIE SALPETRIERE APHP, Réanimation Neuro-Chirurgicale
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Kontakt:
- Vincent DEGOS, Professor
- Telefonnummer: +33142160000
- E-mail: vincent.degos@inserm.fr
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Poitiers, Frankrig
- CHU LA MILETRIE, réanimation neurochirurgicale
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Kontakt:
- Claire DAHYOT, Professor
- Telefonnummer: +33549444230
- E-mail: Claire.DAHYOT-FIZELIER@chu-poitiers.fr
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Rennes, Frankrig
- Chru Rennes Site Pontchaillou
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Kontakt:
- Yoann LAUNEY, Professor
- Telefonnummer: +33299284321
- E-mail: yoann.launey@chu-rennes.fr
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Strasbourg, Frankrig
- Hôpital de Hautepierre
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Kontakt:
- Julien POTTECHER, Professor
- Telefonnummer: +33388127066
- E-mail: julien.pottecher@chru-strasbourg.fr
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Talence, Frankrig
- Hopital Haut-Leveque - Chu
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Kontakt:
- Olivier JOANNES-BOYAU, Doctor
- Telefonnummer: +33556795679
- E-mail: olivier.joannes-boyau@chu-bordeaux.fr
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Toulouse, Frankrig
- Hopital Purpan Chu Toulouse
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Kontakt:
- Thomas GEERAERTS, Professor
- Telefonnummer: +33562746164
- E-mail: geeraerts.t@chu-toulouse.fr
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Tours, Frankrig
- Chru Trousseau - Chambray
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Kontakt:
- Fabien ESPITALIER, Professor
- Telefonnummer: +33247479040
- E-mail: f.espitalier@chu-tours.fr
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
adult patients hospitalized in intensive care for ≥2 days
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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evaluate the impact of multifaceted support for STOP-A implementation on hospital mortality, taking into account the stepped wedge design structure.
Tidsramme: Day 0 to Day 90
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in-hospital mortality, up to day 90
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Day 0 to Day 90
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Evaluate the impact of implementation support on Hb levels
Tidsramme: hospital discharge or day 28
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hemoglobin level in g/dl
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hospital discharge or day 28
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Assess the impact of implementation support on recovery after ICU discharge.
Tidsramme: Day 90
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number of days living in the previous place of residence prior to D90
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Day 90
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Evaluate impact of implementation support on longer-term mortality
Tidsramme: 6 Months
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all-cause mortality at 6 months
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6 Months
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Assess the impact of implementation support on survival
Tidsramme: 6 months
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6-month survival curves
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6 months
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Assess the impact of implementation support (STOP-A) on professional practices
Tidsramme: From enrollment to the end of recruitment
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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
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From enrollment to the end of recruitment
|
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Assess the impact of implementation support on transfusion use between the two phases.
Tidsramme: 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
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Assess impact of implementation support on transfusion use between the two phases.
Tidsramme: From enrollment to the end of recruitment
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transfusion index relative to the number of hospitalized patients in each phase
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From enrollment to the end of recruitment
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Assess the impact of implementation support on transfusion use between the two phases.
Tidsramme: 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
|
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Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase
Tidsramme: day 90
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The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed in subgroups of patients with an IRR >75% vs. <20%;
|
day 90
|
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Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase
Tidsramme: day 90
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The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed according to IRR quartiles.
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day 90
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Evaluate the impact of implementation support (STOP-A) in traumatized and non-traumatized patients.
Tidsramme: Day 90
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Day 90
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Evaluate the impact of EPO treatment in patients with Hb<12 g/dL
Tidsramme: Day 90
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Day 90
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|
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Evaluate the impact of implementation support (STOP-A) on complications due to healthcare
Tidsramme: hospital discharge or day 28
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thromboembolic events occurring in intensive care
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hospital discharge or day 28
|
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Evaluate the impact of implementation support (STOP-A) on complications due to healthcare
Tidsramme: hospital discharge or day 28
|
transfusion-related adverse events
|
hospital discharge or day 28
|
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Evaluate the efficiency of assistance in implementing RFEs (STOP-A) through a cost-effectiveness analysis.
Tidsramme: day 180
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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.
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day 180
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. januar 2028
Studieafslutning (Anslået)
1. marts 2028
Datoer for studieregistrering
Først indsendt
30. juli 2026
Først indsendt, der opfyldte QC-kriterier
13. august 2026
Først opslået (Faktiske)
18. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. august 2026
Sidst verificeret
1. oktober 2025
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 49RC25_0386
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
IPD-delingsadgangskriterier
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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