Investigation of Ferritin in Critically Ill Patients With Hemophagocytic Lymphohistiocytosis

Hemophagocytic Lymphohistiocytosis (HLH) Clinical Trial

— FERRITS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854943
• Other study ID #: HLH
• Status: Completed
• Start date: January 2000
• Est. completion date: August 2018

Study information

• Verified date: December 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2623
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male and female patients
• at least one measurement of plasma ferritin Exclusion Criteria: -age below 18 years

Related Conditions & MeSH terms

• Critical Illness
• Hemophagocytic Lymphohistiocytosis (HLH)
• Lymphohistiocytosis, Hemophagocytic
• Macrophage Activation Syndrome
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gunnar Lachmann

References & Publications (2)

Fardet L, Galicier L, Lambotte O, Marzac C, Aumont C, Chahwan D, Coppo P, Hejblum G. Development and validation of the HScore, a score for the diagnosis of reactive hemophagocytic syndrome. Arthritis Rheumatol. 2014 Sep;66(9):2613-20. doi: 10.1002/art.38690. — View Citation

Henter JI, Horne A, Arico M, Egeler RM, Filipovich AH, Imashuku S, Ladisch S, McClain K, Webb D, Winiarski J, Janka G. HLH-2004: Diagnostic and therapeutic guidelines for hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2007 Feb;48(2):124-31. doi: 10.1002/pbc.21039. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	A retrospective analysis of patients with available charts to determine the outcome whether patients survived the ICU or died.	Participants will be followed up for the duration of hospital stay, an expected average of two months
Primary	Probability of having undiagnosed Hemophagocytic lymphohistiocytosis (HLH)	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)	The participants will be followed up for the duration of hospital stay, an expected average of two months
Secondary	Diagnoses	Retrospective analysis of available charts and underlying diagnoses	Participants will be followed up for the duration of hospital stay, an expected average of two months
Secondary	Intensive care unit stay	Retrospective analysis of available charts and duration of ICU stay	Participants will be followed up for the duration of intensive care unit stay, an expected average of one week
Secondary	Improving HLH diagnostic criteria including multicenter validation	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.	Participants will be followed up for the duration of intensive care unit stay, an expected average of one week