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Hemophagocytosis in Critically Ill Adult Patients (HCIAP)

U

University of Ulm

Status

Enrolling

Conditions

Hemophagocytosis

Study type

Observational

Funder types

Other

Identifiers

NCT01913938
Hemophagocytosis_Ulm

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

patients with cytopenias
Description:
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.

Trial contacts and locations

2

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Central trial contact

Manfred E Weiss, MD; Elisabeth M Schneider, PhD

Data sourced from clinicaltrials.gov

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