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NCT Number: NCT07771192

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

réanimation médicale CHU ANGERS, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. evaluate the impact of multifaceted support for STOP-A implementation on hospital mortality, taking into account the stepped wedge design structure.

    Time frame: Day 0 to Day 90

    in-hospital mortality, up to day 90

Secondary outcomes

  1. Evaluate the impact of implementation support on Hb levels

    Time frame: hospital discharge or day 28

    hemoglobin level in g/dl

  2. Assess the impact of implementation support on recovery after ICU discharge.

    Time frame: Day 90

    number of days living in the previous place of residence prior to D90

  3. Evaluate impact of implementation support on longer-term mortality

    Time frame: 6 Months

    all-cause mortality at 6 months

  4. Assess the impact of implementation support on survival

    Time frame: 6 months

    6-month survival curves

  5. Assess the impact of implementation support (STOP-A) on professional practices

    Time frame: 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

  6. Assess the impact of implementation support on transfusion use between the two phases.

    Time frame: From enrollment to the end of recruitment

    Rate of transfused patients relative to the number of hospitalized patients in each phase

  7. Assess impact of implementation support on transfusion use between the two phases.

    Time frame: From enrollment to the end of recruitment

    transfusion index relative to the number of hospitalized patients in each phase

  8. Assess the impact of implementation support on transfusion use between the two phases.

    Time frame: From enrollment to the end of recruitment

    the number of red blood cell units relative to the number of hospitalized patients

  9. Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase

    Time frame: day 90

    The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed in subgroups of patients with an IRR >75% vs. <20%;

  10. Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase

    Time frame: day 90

    The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed according to IRR quartiles.

  11. Evaluate the impact of implementation support (STOP-A) in traumatized and non-traumatized patients.

    Time frame: Day 90

  12. Evaluate the impact of EPO treatment in patients with Hb<12 g/dL

    Time frame: Day 90

  13. Evaluate the impact of implementation support (STOP-A) on complications due to healthcare

    Time frame: hospital discharge or day 28

    thromboembolic events occurring in intensive care

  14. Evaluate the impact of implementation support (STOP-A) on complications due to healthcare

    Time frame: hospital discharge or day 28

    transfusion-related adverse events

  15. Evaluate the efficiency of assistance in implementing RFEs (STOP-A) through a cost-effectiveness analysis.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sigismond LASOCKI, Professor

CONTACT

[email protected]

02 41 35 36 35

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: STOP-A

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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