Hemophagocytosis in Critically Ill Adult Patients

Hemophagocytosis in Critically Ill Adult Patients With Cytopenias

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01913938

Acronym

HCIAP

Enrollment

Registered

2013-08-01

Start date

2013-07-31

Completion date

2026-12-31

Last updated

2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophagocytosis

Keywords

Hemophagocytosis, adults, rhG-CSF

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
responsiveness to recombinant human granulocyte colony-stimulating factor (rhG-CSF)	within 7 days	increase in leukocytes

Secondary

Measure	Time frame	Description
8 clinical HLH criteria	7 days	degree of fulfillment x out of 8 clinical HLH criteria

Other

Measure	Time frame	Description
differential blood count, enzymes,biomarkers,immunophenotype	7 days	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)

Countries

Germany

Contacts

Primary ContactManfred E Weiss, MD

manfred.weiss@uniklinik-ulm.de49-731-50060226

Backup ContactElisabeth M Schneider, PhD

marion.schneider@uni-ulm.de49-731-50060080

Outcome results