Hemophagocytosis in Critically Ill Adult Patients

Hemophagocytosis Clinical Trial

— HCIAP  

Official title:

Hemophagocytosis in Critically Ill Adult Patients With Cytopenias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01913938
• Other study ID #: Hemophagocytosis_Ulm
• Status: Recruiting
• Start date: July 2013
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: University of Ulm
• Contact: Manfred E Weiss, MD
• Phone: 49-731-50060226
• Email: manfred.weiss[@]uniklinik-ulm.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Hemophagocytosis

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology, University Hospital Ulm	Ulm
Germany	Department of Internal Medicine III, Comprehensive Infectious Disease Center, University Hospital Ulm, Germany	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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

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. 2 — View 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. — View 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

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	responsiveness to recombinant human granulocyte colony-stimulating factor (rhG-CSF)	increase in leukocytes	within 7 days
Secondary	8 clinical HLH criteria	degree of fulfillment x out of 8 clinical HLH criteria	7 days