Skip to main content
OpenTrials
Recruiting

NCT Number: NCT01913938

Hemophagocytosis in Critically Ill Adult Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hemophagocytosis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology, University Hospital Ulm, Ulm, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: within 7 days

    increase in leukocytes

Secondary outcomes

  1. 8 clinical HLH criteria

    Time frame: 7 days

    degree of fulfillment x out of 8 clinical HLH criteria

Other outcomes

  1. differential blood count, enzymes,biomarkers,immunophenotype

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabeth M Schneider, PhD

CONTACT

[email protected]

49-731-50060080

Manfred E Weiss, MD

CONTACT

[email protected]

49-731-50060226

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

Hemophagocytosis in Critically Ill Adult Patients With Cytopenias

Acronym: HCIAP

Important dates

Study start
2013
Primary completion
2025
Study completion
2026
First posted
Aug 1, 2013
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.