Hemophagocytosis in Critically Ill Adult Patients

NCT ID: NCT01913938

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemophagocytosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Manfred Weiss

Professor, MD, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manfred E Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology

Locations

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Department of Anaesthesiology, University Hospital Ulm

Ulm, , Germany

Site Status RECRUITING

Department of Internal Medicine III, Comprehensive Infectious Disease Center, University Hospital Ulm, Germany

Ulm, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Manfred E Weiss, MD

Role: CONTACT

49-731-50060226

Elisabeth M Schneider, PhD

Role: CONTACT

49-731-50060080

Facility Contacts

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Manfred E Weiss, MD

Role: primary

49 (0)731-500-60226

Elisabeth M Schneider, PhD

Role: backup

49 (0)731-500-60319

Martin Bommer, MD

Role: primary

+49 (731) 500-45530

Elisabeth M Schneider, PhD

Role: backup

+49 (731) 500-60080

References

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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.

Reference Type BACKGROUND
PMID: 12351400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16937360 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type RESULT
PMID: 21484192 (View on PubMed)

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

Reference Type RESULT

Other Identifiers

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Hemophagocytosis_Ulm

Identifier Type: -

Identifier Source: org_study_id

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