NCT01913938|Recruiting
Hemophagocytosis in Critically Ill Adult Patients
HCIAP
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HCIAP
Sponsor study identifier
observational
40
1 country
2
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of the study is to find out whether non-responsiveness to therapeutic recombinant human granulocyte colony-stimulation factor (rhG-CSF) is associated with hemophagocytosis in critically ill adult patients with cytopenias.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 29, 2013
Actual (reported)August 1, 2013
Actual (reported)July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
responsiveness to recombinant human granulocyte colony-stimulating factor (rhG-CSF)
increase in leukocytes
within 7 days
8 clinical HLH criteria
7 days
differential blood count, enzymes,biomarkers,immunophenotype
7 days
Patients with sepsis and concomitant cytopenias (leukopenia with thrombocytopenia and anemia) who are routinely treated with rhG-CSF will be followed for reconstitution of peripheral blood cell counts. In cooperation with the Department of Hematology, patients are examined for bone marrow cellularity and hemophagocytosis if G-CSF treatment does not result in leukocyte increase.
Patients with leukopenia who are routinely treated with rhG-CSF
Department of Anaesthesiology, University Hospital Ulm
Ulm, 89075, Germany
Department of Internal Medicine III, Comprehensive Infectious Disease Center, University Hospital Ulm, Germany
Ulm, 89075, Germany
Schneider EM, Lorenz I, Muller-Rosenberger M, Steinbach G, Kron M, Janka-Schaub GE. Hemophagocytic lymphohistiocytosis is associated with deficiencies of cellular cytolysis but normal expression of transcripts relevant to killer-cell-induced apoptosis. Blood. 2002 Oct 15;100(8):2891-8. doi: 10.1182/blood-2001-12-0260.
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.
whole blood, serum, white cells, bone marrow
Manfred E Weiss, MD
Department of Anesthesiology
First Submitted
July 29, 2013
First Posted
August 1, 2013
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2025
Estimated (date passed)Contact the study team to confirm eligibility.
Weiss M, Nass M, Schneider EM. Hemophagocytic and/or macrophage activation syndromes may explain thrombocytopenia, leukopenia and anemia in critically ill postoperative/posttraumatic patients. Infection, vol. 39 Suppl. II September, no., pp. S118, 2011.
Lorenz MR, Walther P, Weiss M, Huber-Lang M, Schneider EM. Autophagy as a unique biosignature in hemophagocytic cells of patients after major trauma. Infection, vol. 37 (Suppl. III), no. P111, pp. S28 - 29, 2009.
Schneider EM, Flacke S, Liu F, Lorenz MR, Schilling P, Nass ME, Foehr KJ, Huber-Lang M, Weiss ME. Autophagy and ATP-induced anti-apoptosis in antigen presenting cells (APC) follows the cytokine storm in patients after major trauma. J Cell Commun Signal. 2011 Jun;5(2):145-56. doi: 10.1007/s12079-010-0113-z. Epub 2011 Jan 13.
Weiss M, Bommer M, Hohmann H, Walther P, Schneider EM. The clinical definition of hemophagocytic lymphohistiocytosis (HLH) as used in children does not explain cytopenia in the majority of critically ill postoperative/posttraumatic patients. Infection 41 Suppl 1: S43 - S44, 2013. DOI 10.1007/s15010-013-0513-0
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 17, 2024
Record last verified: 2024-01
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