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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with cytopenias | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| responsiveness to recombinant human granulocyte colony-stimulating factor (rhG-CSF) | increase in leukocytes | within 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 8 clinical HLH criteria | degree of fulfillment x out of 8 clinical HLH criteria | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| differential blood count, enzymes,biomarkers,immunophenotype | Differential blood count, lactate dehydrogenase, C reactive protein, fibrinogen, triglycerides, ferritin,liver enzymes, aspartate aminotransferase, soluble cluster of differentiation 25, cytokines, procalcitonin biomarkers,immunophenotype (flow cytometry) | 7 days |
Inclusion Criteria:
Exclusion Criteria:
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Patients with leukopenia who are routinely treated with rhG-CSF
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manfred E Weiss, MD | Contact | 49-731-50060226 | manfred.weiss@uniklinik-ulm.de | |
| Elisabeth M Schneider, PhD | Contact | 49-731-50060080 | marion.schneider@uni-ulm.de |
| Name | Affiliation | Role |
|---|---|---|
| Manfred E Weiss, MD | Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology, University Hospital Ulm | Recruiting | Ulm | 89075 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12351400 | Background | 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. | |
| 16937360 |
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whole blood, serum, white cells, bone marrow
| Department of Internal Medicine III, Comprehensive Infectious Disease Center, University Hospital Ulm, Germany | Recruiting | Ulm | 89075 | Germany |
|
| 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. |
| Result | 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. |
| Result | 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. |
| 21484192 | Result | 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. |
| Result | 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 |