NCT03510650|Completed
Loading search results
Sponsor study identifier
observational
100
1 country
1
Study Start
September 11, 2018
Actual (reported)Primary Completion
June 26, 2022
Actual (reported)Study Completion
December 26, 2022
Actual (reported)Hemophagocytic lymphohistiocytosis in adults (HLH) is at 68% mortality whereas 78% of all cases remain undiagnosed though therapies are available which clearly reduce mortality. The investigators aim to systematically investigate this life-threatening hyperinflammatory syndrome in intensive care units (ICU) in order to detect biomarkers that are highly sensitive and highly specific for HLH in ICU compared to patients with sepsis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 26, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 5, 2018
Actual (reported)April 27, 2018
Actual (reported)September 11, 2018
Actual (reported)June 26, 2022
Actual (reported)December 26, 2022
Actual (reported)Incidence of HLH in intensive care units based on HLH-2004 criteria
HLH patients are followed up until the end of hospital stay or death.
Up to 180 days
Intensive care unit stay
Participants will be followed up for the duration of hospital length of stay, an expected average of 4 weeks
Hospital stay
Participants will be followed up for the duration of hospital length of stay, an expected average of 8 weeks
Mortality
Up to 180 days
Cytokine panel
Up to 180 days
Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) viral loads
Up to 180 days
HLA Typing
At the beginning of the investigation
50 patients with sepsis versus 50 patients with HLH \[anticipated\]
Male and female critically ill patients admitted to any ICU of the Charité - Universitätsmedizin Berlin.
Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Barba T, Maucort-Boulch D, Iwaz J, Bohe J, Ninet J, Hot A, Lega JC, Guerin C, Argaud L, Broussolle C, Jamilloux Y, Richard JC, Seve P. Hemophagocytic Lymphohistiocytosis in Intensive Care Unit: A 71-Case Strobe-Compliant Retrospective Study. Medicine (Baltimore). 2015 Dec;94(51):e2318. doi: 10.1097/MD.0000000000002318.
Lachmann G, Knaak C, von Haefen C, Paeschke N, Meisel C, Nyvlt P, Schuster FS, Piper SK, Kruppa J, Vorderwulbecke G, Balzer F, La Rosee P, Schenk T, Unterwalder N, Kolsch U, Lachmann N, Akyuz L, Brunkhorst FM, Volk HD, Keh D, Spies C. Diagnostic biomarkers for adult haemophagocytic lymphohistiocytosis in critically ill patients (HEMICU): a prospective observational study protocol. BMJ Open. 2019 Oct 30;9(10):e032695. doi: 10.1136/bmjopen-2019-032695.
6 ml of blood samples of each patient will be stored in the Biobank of the Berlin Institute of Health, Clinical Research Unit, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, D-13353 Berlin
Claudia Spies, MD, Prof.
Charite University, Berlin, Germany
100 participants (actual enrollment reported by the registry).
First Submitted
April 5, 2018
First Posted
April 27, 2018
Study Start
September 11, 2018
Actual (reported)Ruxolitinib Combined With Dexamethasone for HLH
Contact the study team to confirm eligibility.
Primary Completion
June 26, 2022
Actual (reported)Study Completion
December 26, 2022
Actual (reported)Last Updated
January 4, 2023
Record last verified: 2023-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: