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 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
5760
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sigismond LASOCKI, Professor
- Telefonnummer: 02 41 35 36 35
- E-post: silasocki@chu-angers.fr
Studiesteder
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Angers, Frankrike, 49000
- réanimation médicale CHU ANGERS
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Ta kontakt med:
- Pierre ASFAR, Professor
- Telefonnummer: +33241355865
- E-post: piasfar@chu-angers.fr
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Argenteuil, Frankrike
- Ch Victor Dupouy
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Ta kontakt med:
- Gaëtan PLANTEFEVE, Doctor
- Telefonnummer: +33134233318
- E-post: gaetan.plantefeve@ch-argenteuil.fr
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Brest, Frankrike
- CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation chirurgicale
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Ta kontakt med:
- Olivier LANGERON, Professor
- Telefonnummer: +33298223333
- E-post: olivier.langeron@chu-brest.fr
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Brest, Frankrike
- CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation médicale
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Ta kontakt med:
- Cécile AUBRON, Doctor
- Telefonnummer: +33298223333
- E-post: cecile.aubron@chu-brest.fr
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Chartres, Frankrike
- Ch Chartres Louis Pasteur-Le Coudray
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Ta kontakt med:
- Juliette AUDIBERT, Doctor
- Telefonnummer: +33237303030
- E-post: Jaudibert@ch-chartres.fr
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Cholet, Frankrike
- CH de Cholet
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Ta kontakt med:
- Antony LEMEUR, Doctor
- Telefonnummer: +33241496398
- E-post: antony.lemeur@ch-cholet.fr
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Clermont-Ferrand, Frankrike
- HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Médico-Chrirugicale
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Ta kontakt med:
- Emmanuel FUTIER, Doctor
- Telefonnummer: +33473750750
- E-post: efutier@chu-clermontferrand.fr
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Clermont-Ferrand, Frankrike
- HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Neurochirurgicale
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Ta kontakt med:
- Russell CHABANNE, Doctor
- Telefonnummer: +33473750750
- E-post: rchabanne@chu-clermontferrand.fr
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Grenoble, Frankrike
- CHU Grenoble-HOPITAL SUD - CHU38
-
Ta kontakt med:
- Pierre BOUZAT, Professor
- Telefonnummer: +33476765295
- E-post: PBouzat@chu-grenoble.fr
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Laval, Frankrike
- CH de LAVAL
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Ta kontakt med:
- Hussein YASSINE
- Telefonnummer: +33 2 43 66 50 00
- E-post: hussein.yassine@chlaval.fr
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Le Mans, Frankrike
- Centre Hospitalier du Mans
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Ta kontakt med:
- Christophe GUITTON, Professor
- Telefonnummer: +33243434343
- E-post: cguitton@ch-lemans.fr
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Montpellier, Frankrike
- Hopital St Eloi Chu Montpellier
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Ta kontakt med:
- Samir JABER, Professor
- Telefonnummer: +33467330262
- E-post: s-jaber@chu-montpellier.fr
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Nancy, Frankrike
- Chru Nancy - Hopitaux de Brabois
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Ta kontakt med:
- Antoine KIMMOUN, Doctor
- Telefonnummer: 383153030
- E-post: akimmoun@gmail.com
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Nantes, Frankrike
- Hopital Laenec, CHU Nantes
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Ta kontakt med:
- Karim LAKHAL, Professor
- Telefonnummer: +33240083333
- E-post: Karim.LAKHAL@chu-nantes.fr
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Nantes, Frankrike
- Hôtel Dieu, CHU Nantes
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Ta kontakt med:
- ANTOINE ROQUILLY, Professor
- Telefonnummer: +33253009191
- E-post: Antoine.ROQUILLY@chu-nantes.fr
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Paris, Frankrike
- Gcs Irm Beaujon Moleculaire Act, Ap-Hp
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Ta kontakt med:
- Emmanuel WEISS, Professor
- Telefonnummer: +33140874403
- E-post: emmanuel.weiss@aphp.fr
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Paris, Frankrike
- Hopital Cochin Tarnier Aphp
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Ta kontakt med:
- Frederic PENE, Professor
- Telefonnummer: +33158414141
- E-post: frederic.pene@aphp.fr
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Paris, Frankrike
- Hu Est Parisien Site St Antoine Aphp
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Ta kontakt med:
- Franck VERDONK, Doctor
- Telefonnummer: +33149282000
- E-post: franck.verdonk@aphp.fr
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Paris, Frankrike
- Hu Paris Nord Site Bichat Aphp
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Ta kontakt med:
- Charles Philippe MONTRAVERS, Professor
- Telefonnummer: +33140257910
- E-post: philippe.montravers@aphp.fr
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Paris, Frankrike
- HU PITIE SALPETRIERE APHP, Réanimation Chirurgicale
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Ta kontakt med:
- Jean-Michel CONSTANTIN, Professor
- Telefonnummer: +33142160000
- E-post: jean-michel.constantin@aphp.fr
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Paris, Frankrike
- HU PITIE SALPETRIERE APHP, Réanimation Neuro-Chirurgicale
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Ta kontakt med:
- Vincent DEGOS, Professor
- Telefonnummer: +33142160000
- E-post: vincent.degos@inserm.fr
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Poitiers, Frankrike
- CHU LA MILETRIE, réanimation neurochirurgicale
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Ta kontakt med:
- Claire DAHYOT, Professor
- Telefonnummer: +33549444230
- E-post: Claire.DAHYOT-FIZELIER@chu-poitiers.fr
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Rennes, Frankrike
- Chru Rennes Site Pontchaillou
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Ta kontakt med:
- Yoann LAUNEY, Professor
- Telefonnummer: +33299284321
- E-post: yoann.launey@chu-rennes.fr
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Strasbourg, Frankrike
- Hôpital de Hautepierre
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Ta kontakt med:
- Julien POTTECHER, Professor
- Telefonnummer: +33388127066
- E-post: julien.pottecher@chru-strasbourg.fr
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Talence, Frankrike
- Hopital Haut-Leveque - Chu
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Ta kontakt med:
- Olivier JOANNES-BOYAU, Doctor
- Telefonnummer: +33556795679
- E-post: olivier.joannes-boyau@chu-bordeaux.fr
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Toulouse, Frankrike
- Hopital Purpan Chu Toulouse
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Ta kontakt med:
- Thomas GEERAERTS, Professor
- Telefonnummer: +33562746164
- E-post: geeraerts.t@chu-toulouse.fr
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Tours, Frankrike
- Chru Trousseau - Chambray
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Ta kontakt med:
- Fabien ESPITALIER, Professor
- Telefonnummer: +33247479040
- E-post: f.espitalier@chu-tours.fr
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
in-hospital mortality, up to day 90
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Day 0 to Day 90
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
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Rate of transfused patients 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 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
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the number of red blood cell units relative to the number of hospitalized patients
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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.
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. januar 2028
Studiet fullført (Antatt)
1. mars 2028
Datoer for studieregistrering
Først innsendt
30. juli 2026
Først innsendt som oppfylte QC-kriteriene
13. august 2026
Først lagt ut (Faktiske)
18. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. august 2026
Sist bekreftet
1. oktober 2025
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 49RC25_0386
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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