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

NCT07771192 — Not yet recruiting, 5760 participants, University Hospital, Angers

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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

RegistryNCT07771192, acronym STOP-A
StatusNot yet recruiting
Study typeObservational
Enrollment5760 (Estimated)
SponsorUniversity Hospital, Angers (Other gov)
ConditionsAnemia
Interventionsimplementation of recommendations (Other)
Datesstart 2026-09-01 (estimated), primary completion 2028-01-01 (estimated), completion 2028-03-01 (estimated), first posted 2026-08-18, last updated 2026-08-18
Locations27 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for Anemia All trials of implementation of recommendations

-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.

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+Arms and interventions

  • implementation of recommendations (Other): 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.

+Outcome measures

Primary outcomes

  • evaluate the impact of multifaceted support for STOP-A implementation on hospital mortality, taking into account the stepped wedge design structure. [Day 0 to Day 90]: in-hospital mortality, up to day 90

Secondary outcomes

  • Evaluate the impact of implementation support on Hb levels [hospital discharge or day 28]: hemoglobin level in g/dl
  • Assess the impact of implementation support on recovery after ICU discharge. [Day 90]: number of days living in the previous place of residence prior to D90
  • Evaluate impact of implementation support on longer-term mortality [6 Months]: all-cause mortality at 6 months
  • Assess the impact of implementation support on survival [6 months]: 6-month survival curves
  • Assess the impact of implementation support (STOP-A) on professional practices [From enrollment to the end of recruitment]: 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
  • Assess the impact of implementation support on transfusion use between the two phases. [From enrollment to the end of recruitment]: Rate of transfused patients relative to the number of hospitalized patients in each phase
  • Assess impact of implementation support on transfusion use between the two phases. [From enrollment to the end of recruitment]: transfusion index relative to the number of hospitalized patients in each phase
  • Assess the impact of implementation support on transfusion use between the two phases. [From enrollment to the end of recruitment]: the number of red blood cell units relative to the number of hospitalized patients
  • Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase [day 90]: The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed in subgroups of patients with an IRR >75% vs. <20%;
  • Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase [day 90]: The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed according to IRR quartiles.
  • Evaluate the impact of implementation support (STOP-A) in traumatized and non-traumatized patients. [Day 90]
  • Evaluate the impact of EPO treatment in patients with Hb<12 g/dL [Day 90]
  • Evaluate the impact of implementation support (STOP-A) on complications due to healthcare [hospital discharge or day 28]: thromboembolic events occurring in intensive care
  • Evaluate the impact of implementation support (STOP-A) on complications due to healthcare [hospital discharge or day 28]: transfusion-related adverse events
  • Evaluate the efficiency of assistance in implementing RFEs (STOP-A) through a cost-effectiveness analysis. [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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (27)

FacilityCityCountryStatus
réanimation médicale CHU ANGERSAngersFrance
Ch Victor DupouyArgenteuilFrance
CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation chirurgicaleBrestFrance
CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation médicaleBrestFrance
Ch Chartres Louis Pasteur-Le CoudrayChartresFrance
Ch de CholetCholetFrance
HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Médico-ChrirugicaleClermont-FerrandFrance
HOPITAL GABRIEL MONTPIED - CHU63, Réanimation NeurochirurgicaleClermont-FerrandFrance
CHU Grenoble-HOPITAL SUD - CHU38GrenobleFrance
CH de LAVALLavalFrance
Centre Hospitalier Du MansLe MansFrance
Hopital St Eloi Chu MontpellierMontpellierFrance
Chru Nancy - Hopitaux de BraboisNancyFrance
Hopital Laenec, CHU NantesNantesFrance
Hôtel Dieu, CHU NantesNantesFrance
Gcs Irm Beaujon Moleculaire Act, Ap-HpParisFrance
Hopital Cochin Tarnier AphpParisFrance
Hu Est Parisien Site St Antoine AphpParisFrance
Hu Paris Nord Site Bichat AphpParisFrance
HU PITIE SALPETRIERE APHP, Réanimation ChirurgicaleParisFrance
HU PITIE SALPETRIERE APHP, Réanimation Neuro-ChirurgicaleParisFrance
CHU LA MILETRIE, réanimation neurochirurgicalePoitiersFrance
Chru Rennes Site PontchaillouRennesFrance
Hopital de HautepierreStrasbourgFrance
Hopital Haut-Leveque - ChuTalenceFrance
Hopital Purpan Chu ToulouseToulouseFrance
Chru Trousseau - ChambrayToursFrance