Hemophagocytosis in Critically Ill Adult Patients

Recruiting

• Conditions: Hemophagocytosis

• Registration Number: NCT01913938
• Lead Sponsor: University of Ulm

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-08-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-17
• Primary Completion: 2025-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
8 clinical HLH criteria	7 days	degree of fulfillment x out of 8 clinical HLH criteria

Trial Locations

Locations (2)

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

Department of Anaesthesiology, University Hospital Ulm; 🇩🇪 Ulm, Germany