Study Evaluating Multifaceted Support for the Implementation of Recommendations for the Prevention and Management of Anemia in Intensive Care Units (STOP-A)
13 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
5760
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Sigismond LASOCKI, Professor
- Telefonnummer: 02 41 35 36 35
- E-post: silasocki@chu-angers.fr
Studieorter
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Angers, Frankrike, 49000
- réanimation médicale CHU ANGERS
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Kontakt:
- Pierre ASFAR, Professor
- Telefonnummer: +33241355865
- E-post: piasfar@chu-angers.fr
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Argenteuil, Frankrike
- Ch Victor Dupouy
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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- Juliette AUDIBERT, Doctor
- Telefonnummer: +33237303030
- E-post: Jaudibert@ch-chartres.fr
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Cholet, Frankrike
- CH de Cholet
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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- Russell CHABANNE, Doctor
- Telefonnummer: +33473750750
- E-post: rchabanne@chu-clermontferrand.fr
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Grenoble, Frankrike
- CHU Grenoble-HOPITAL SUD - CHU38
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Kontakt:
- Pierre BOUZAT, Professor
- Telefonnummer: +33476765295
- E-post: PBouzat@chu-grenoble.fr
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Laval, Frankrike
- CH de LAVAL
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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- Antoine KIMMOUN, Doctor
- Telefonnummer: 383153030
- E-post: akimmoun@gmail.com
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Nantes, Frankrike
- Hopital Laenec, CHU Nantes
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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- Fabien ESPITALIER, Professor
- Telefonnummer: +33247479040
- E-post: f.espitalier@chu-tours.fr
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
adult patients hospitalized in intensive care for ≥2 days
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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.
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Evaluate the impact of implementation support on Hb levels
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
From enrollment to the end of recruitment
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Assess the impact of implementation support on transfusion use between the two phases.
Tidsram: 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
|
From enrollment to the end of recruitment
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Assess impact of implementation support on transfusion use between the two phases.
Tidsram: 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.
Tidsram: From enrollment to the end of recruitment
|
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
Tidsram: 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
Tidsram: 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.
Tidsram: Day 90
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Day 90
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|
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Evaluate the impact of EPO treatment in patients with Hb<12 g/dL
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 januari 2028
Avslutad studie (Beräknad)
1 mars 2028
Studieregistreringsdatum
Först inskickad
30 juli 2026
Först inskickad som uppfyllde QC-kriterierna
13 augusti 2026
Första postat (Faktisk)
18 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 augusti 2026
Senast verifierad
1 oktober 2025
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 49RC25_0386
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
Kriterier för IPD Sharing Access
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .