Hemophagocytosis in Critically Ill Adult Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUniversity of Ulm

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age > 18 years

critically ill adult patients

leukopenia and thrombocytopenia

rhG-CSF therapy

Disqualifiers

life expectancy < 24 hours

inclusion in other studies

trauma patients with reanimation on scene or immediately dying on hospital admission

pregnancy

Trial population

Patients with leukopenia who are routinely treated with rhG-CSF

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: patients with cytopenias

Trial outcomes

Primary outcomes

1

responsiveness to recombinant human granulocyte colony-stimulating factor (rhG-CSF)

increase in leukocytes

Time frame
within 7 days

Secondary outcomes

1

8 clinical HLH criteria

degree of fulfillment x out of 8 clinical HLH criteria

Time frame
7 days

Other outcomes

1

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)

Time frame
7 days

Sponsors and contacts

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