An observational study in Anemia, sponsored by University Hospital, Angers. Not yet recruiting at 27 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University Hospital, Angers · Observational
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 5,760 is above the median of 270 across 368 observational studies indexed under Anemia.
Browse Anemia studies →University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
Counted across the registry records on this site, refreshed daily.
adult patients hospitalized in intensive care for ≥2 days
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
evaluate the impact of multifaceted support for STOP-A implementation on hospital mortality, taking into account the stepped wedge design structure.
in-hospital mortality, up to day 90
Time frame: Day 0 to Day 90
Evaluate the impact of implementation support on Hb levels
hemoglobin level in g/dl
Time frame: hospital discharge or day 28
Assess the impact of implementation support on recovery after ICU discharge.
number of days living in the previous place of residence prior to D90
Time frame: Day 90
Evaluate impact of implementation support on longer-term mortality
all-cause mortality at 6 months
Time frame: 6 Months
Assess the impact of implementation support on survival
6-month survival curves
Time frame: 6 months
Assess the impact of implementation support (STOP-A) on professional practices
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
Time frame: From enrollment to the end of recruitment
Assess the impact of implementation support on transfusion use between the two phases.
Rate of transfused patients relative to the number of hospitalized patients in each phase
Time frame: From enrollment to the end of recruitment
Assess impact of implementation support on transfusion use between the two phases.
transfusion index relative to the number of hospitalized patients in each phase
Time frame: From enrollment to the end of recruitment
Assess the impact of implementation support on transfusion use between the two phases.
the number of red blood cell units relative to the number of hospitalized patients
Time frame: From enrollment to the end of recruitment
Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase
The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed in subgroups of patients with an IRR \>75% vs. \<20%;
Time frame: day 90
Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase
The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed according to IRR quartiles.
Time frame: day 90
Evaluate the impact of implementation support (STOP-A) in traumatized and non-traumatized patients.
Time frame: Day 90
Evaluate the impact of EPO treatment in patients with Hb<12 g/dL
Time frame: Day 90
Evaluate the impact of implementation support (STOP-A) on complications due to healthcare
thromboembolic events occurring in intensive care
Time frame: hospital discharge or day 28
Evaluate the impact of implementation support (STOP-A) on complications due to healthcare
transfusion-related adverse events
Time frame: hospital discharge or day 28
Evaluate the efficiency of assistance in implementing RFEs (STOP-A) through a cost-effectiveness analysis.
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.
Time frame: day 180
Plan to share: Yes — 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.
Supporting information: Study protocol
Time frame: The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
Access criteria: The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jan 2028, 16 months later.
Of 124 non-industry observational studies under Anemia, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's planned 16 months is below that.
Counting every sponsor, half of 145 studies reached it within 30 months; a quarter within 12 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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