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Investigation of Ferritin in Critically Ill Patients With Hemophagocytic Lymphohistiocytosis

The Prognostic and Diagnostic Value of Ferritin in Critically Ill Patients With Special Focus on Underlying Hemophagocytic Lymphohistiocytosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02854943
Acronym
FERRITS
Enrollment
2623
Registered
2016-08-04
Start date
2000-01-31
Completion date
2018-08-31
Last updated
2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophagocytic Lymphohistiocytosis (HLH), Hemophagocytic Syndromes, Macrophage Activation Syndrome (MAS)

Keywords

Ferritin, Hemophagocytic lymphohistiocytosis (HLH), Critically ill patients, intensive care unit (ICU), Outcome, Diagnosis

Brief summary

Retrospective analysis of ferritin, outcome and HLH-criteria in critically ill patients.

Detailed description

The study is a retrospective register study of critically ill patients from Charité - Universitätsmedizin Berlin during 2000 and 2016 that had at least one measurement of plasma ferritin. Outcome, underlying diagnoses and HLH-2004 criteria (Henter JI et al. 2007) will be analyzed and the HScore of these patients will be calculated (Fardet L et al. 2014). All recorded data of the specific admission term in ICU will be used for the analysis. No follow-up of the patients after discharge will be performed in this study. The study does not involve any randomization or any drug testing. Update 2019: We expanded our database for the years until 2018 and also for the surgical and medical ICUs of the Charité - Universitätsmedizin Berlin (from 256 to 2623 patients). Update 2022: A systematic literature search will be performed to find suitable validation cohorts for multicenter validation of optimized HLH diagnostic criteria, which are calculated based on our data (new secondary endpoint).

Interventions

None listed

Sponsors

Gunnar Lachmann
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* male and female patients * at least one measurement of plasma ferritin

Exclusion criteria

-age below 18 years

Design outcomes

Primary

MeasureTime frameDescription
MortalityParticipants will be followed up for the duration of hospital stay, an expected average of two monthsA retrospective analysis of patients with available charts to determine the outcome whether patients survived the ICU or died.
Probability of having undiagnosed Hemophagocytic lymphohistiocytosis (HLH)The participants will be followed up for the duration of hospital stay, an expected average of two monthsRetrospective analysis of available charts, underlying diagnoses, findings and blood values: HLH-2004 criteria (Henter JI et al. 2007) and HScore (Fardet L et al. 2014)

Secondary

MeasureTime frameDescription
DiagnosesParticipants will be followed up for the duration of hospital stay, an expected average of two monthsRetrospective analysis of available charts and underlying diagnoses
Intensive care unit stayParticipants will be followed up for the duration of intensive care unit stay, an expected average of one weekRetrospective analysis of available charts and duration of ICU stay
Improving HLH diagnostic criteria including multicenter validationParticipants will be followed up for the duration of intensive care unit stay, an expected average of one weekSensitivity and specificity of HLH diagnostic criteria should be improved by calculating different cutoffs of HLH-2004 criteria. Combinations with highest sensitivity and specificity will be validated in published cohorts of HLH testing for sensitivity and specificity.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026