Clinical trial NCT01913938: Hemophagocytosis in Critically Ill Adult Patients
Official title: Hemophagocytosis in Critically Ill Adult Patients With Cytopenias
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemophagocytosis
Keywords: Hemophagocytosis, adults, rhG-CSF
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with leukopenia who are routinely treated with rhG-CSF

Brief summary: 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.

Detailed description: In children with bi- or pancytopenia, hemophagocytosis is known as life-threatening hemophagocytic lymphohistiocytosis (HLH). The purpose of the study is to find out whether adult patients with bicytopenia or pancytopenia fulfilling the clinical HLH criteria used in children reflect life-threatening hemophagocytosis and whether hemophagocytosis is associated with responsiveness to recombinant human granulocyte colony-stimulation factor (rhG-CSF) or not.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* critically ill adult patients
* leukopenia and thrombocytopenia
* rhG-CSF therapy

Exclusion Criteria:

* life expectancy \< 24 hours
* inclusion in other studies
* trauma patients with reanimation on scene or immediately dying on hospital admission
* pregnancy
* hematologic disorder, malignancy
* high dose corticosteroid treatment or chemotherapy

Primary outcomes:
measure: responsiveness to recombinant human granulocyte colony-stimulating factor (rhG-CSF)
timeFrame: within 7 days
Secondary outcomes:
measure: 8 clinical HLH criteria
timeFrame: 7 days
Other outcomes:
measure: differential blood count, enzymes,biomarkers,immunophenotype
timeFrame: 7 days
Locations:
city: Ulm
country: Germany
facility: Department of Anaesthesiology, University Hospital Ulm
city: Ulm
country: Germany
facility: Department of Internal Medicine III, Comprehensive Infectious Disease Center, University Hospital Ulm, Germany
Study officials:
affiliation: Department of Anesthesiology
name: Manfred E Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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