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Completed

NCT Number: NCT02854943

Investigation of Ferritin in Critically Ill Patients With Hemophagocytic Lymphohistiocytosis

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

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Key information

Conditions

Hemophagocytic Lymphohistiocytosis (HLH) Disease Hemic and Lymphatic Diseases Hemophagocytic Syndromes Histiocytosis Histiocytosis, Non-Langerhans-Cell Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphohistiocytosis, Hemophagocytic Lymphoproliferative Disorders Macrophage Activation Syndrome Macrophage Activation Syndrome (MAS) Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

-age below 18 years

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: Participants will be followed up for the duration of hospital stay, an expected average of two months

    A retrospective analysis of patients with available charts to determine the outcome whether patients survived the ICU or died.

  2. Probability of having undiagnosed Hemophagocytic lymphohistiocytosis (HLH)

    Time frame: The participants will be followed up for the duration of hospital stay, an expected average of two months

    Retrospective 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 outcomes

  1. Diagnoses

    Time frame: Participants will be followed up for the duration of hospital stay, an expected average of two months

    Retrospective analysis of available charts and underlying diagnoses

  2. Intensive care unit stay

    Time frame: Participants will be followed up for the duration of intensive care unit stay, an expected average of one week

    Retrospective analysis of available charts and duration of ICU stay

  3. Improving HLH diagnostic criteria including multicenter validation

    Time frame: Participants will be followed up for the duration of intensive care unit stay, an expected average of one week

    Sensitivity 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.

Sponsors and collaborators

Lead sponsor

Gunnar Lachmann

Other

Registry information

Official study title

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

Acronym: FERRITS

Important dates

Study start
2000
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2016
Registry last updated
Dec 7, 2022

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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