NCT01913938

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2013Dec 2026

Study Start

First participant enrolled

July 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

12 years

First QC Date

July 29, 2013

Last Update Submit

January 16, 2024

Conditions

Hemophagocytosis

Keywords

Hemophagocytosis, adults, rhG-CSF

Outcome Measures

Primary Outcomes (1)

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

    increase in leukocytes

    within 7 days

Secondary Outcomes (1)

  • 8 clinical HLH criteria

    7 days

Other Outcomes (1)

  • differential blood count, enzymes,biomarkers,immunophenotype

    7 days

Study Arms (1)

patients with cytopenias

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.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with leukopenia who are routinely treated with rhG-CSF

You may qualify if:

  • age \> 18 years
  • critically ill adult patients
  • leukopenia and thrombocytopenia
  • rhG-CSF therapy

You may not qualify if:

  • life expectancy \< 24 hours
  • trauma patients with reanimation on scene or immediately dying on hospital admission
  • pregnancy
  • hematologic disorder, malignancy
  • high dose corticosteroid treatment or chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anaesthesiology, University Hospital Ulm

Ulm, 89075, Germany

RECRUITING

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

Ulm, 89075, Germany

RECRUITING

Related Publications (6)

  • Schneider EM, Lorenz I, Muller-Rosenberger M, Steinbach G, Kron M, Janka-Schaub GE. Hemophagocytic lymphohistiocytosis is associated with deficiencies of cellular cytolysis but normal expression of transcripts relevant to killer-cell-induced apoptosis. Blood. 2002 Oct 15;100(8):2891-8. doi: 10.1182/blood-2001-12-0260.

    PMID: 12351400BACKGROUND

  • Henter JI, Horne A, Arico M, Egeler RM, Filipovich AH, Imashuku S, Ladisch S, McClain K, Webb D, Winiarski J, Janka G. HLH-2004: Diagnostic and therapeutic guidelines for hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2007 Feb;48(2):124-31. doi: 10.1002/pbc.21039.

    PMID: 16937360BACKGROUND

  • Weiss M, Nass M, Schneider EM. Hemophagocytic and/or macrophage activation syndromes may explain thrombocytopenia, leukopenia and anemia in critically ill postoperative/posttraumatic patients. Infection, vol. 39 Suppl. II September, no., pp. S118, 2011.

    RESULT

  • Lorenz MR, Walther P, Weiss M, Huber-Lang M, Schneider EM. Autophagy as a unique biosignature in hemophagocytic cells of patients after major trauma. Infection, vol. 37 (Suppl. III), no. P111, pp. S28 - 29, 2009.

    RESULT

  • Schneider EM, Flacke S, Liu F, Lorenz MR, Schilling P, Nass ME, Foehr KJ, Huber-Lang M, Weiss ME. Autophagy and ATP-induced anti-apoptosis in antigen presenting cells (APC) follows the cytokine storm in patients after major trauma. J Cell Commun Signal. 2011 Jun;5(2):145-56. doi: 10.1007/s12079-010-0113-z. Epub 2011 Jan 13.

    PMID: 21484192RESULT

  • Weiss M, Bommer M, Hohmann H, Walther P, Schneider EM. The clinical definition of hemophagocytic lymphohistiocytosis (HLH) as used in children does not explain cytopenia in the majority of critically ill postoperative/posttraumatic patients. Infection 41 Suppl 1: S43 - S44, 2013. DOI 10.1007/s15010-013-0513-0

    RESULT

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, bone marrow

Study Officials

  • Manfred E Weiss, MD

    Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manfred E Weiss, MD

CONTACT

49-731-50060226manfred.weiss@uniklinik-ulm.de

Elisabeth M Schneider, PhD

CONTACT

49-731-50060080marion.schneider@uni-ulm.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, MBA

Study Record Dates

First Submitted

July 29, 2013

First Posted

August 1, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations

DE(2)