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Sepsis-Associated Purpura Fulminans International Registry - Europe (SAPFIRE)

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ClinicalTrials.gov Identifier: NCT02238795
Recruitment Status : Recruiting
First Posted : September 12, 2014
Last Update Posted : April 10, 2019
Sponsor:
Collaborators:
Ludwig-Maximilians - University of Munich
Medical University of Vienna
University Hospital Tuebingen
University Hospital of Cologne
University Hospital, Essen
University Hospital Inselspital, Berne
Hannover Medical School
University Hospital, Basel, Switzerland
Evangelisches Krankenhaus Bielefeld gGmbH
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Jena University Hospital

Brief Summary:

Sepsis-associated Purpura fulminans (SAPF) is a rare life-threatening condition. It is characterized by multiple skin lesions which rapidly progress to necrosis and gangrene. SAPF is a manifestation of widespread clot formation in small blood vessels which emerges secondarily to severe bacterial and viral infections. The clinical presentation of SAPF is dominated by symptoms of severe sepsis and multiple organ failure which are further aggravated by the massive skin lesions.

At present, there are no evidence-based guidelines for the medical management of SAPF. With numerous therapeutic approaches in use, there are no consistent comparisons of their efficacy. Altered role of causal pathogens following the introduction of meningococcal and pneumococcal prophylactic vaccines also remains to be investigated.

The goal of the registry is comprehensive collection and evaluation of information concerning the epidemiology, morbidity, therapy and outcome of SAPF.


Condition or disease
Sepsis

Detailed Description:

Purpura fulminans is the clinical manifestation of disseminated thrombosis in dermal and systemic microcirculation. This rare disease is frequently associated with multiple organ failure and represents a life-threatening condition with mortality exceeding 50 %. In the vast proportion of cases, the condition has been shown to emerge secondary to acquired Protein C deficiency associated with severe sepsis, mostly of meningococcal or pneumococcal origin.

A consistent therapeutic approach to sepsis-associated Purpura fulminans (SAPF) has not been established yet. With exaggerated pro-coagulant activity being confirmed as the key pathogenic aspect, several treatment modalities aiming at the balance restoration in the coagulation cascade have been considered.

SAPF causality might have been substantially altered in the wake of widespread meningococcal and pneumococcal vaccination. There are neither evidence-based treatment guidelines nor comparative evaluation of the efficacy of different therapeutic approaches.

The present registry aims at a) large-scale data accumulation and comprehensive evaluation of the incidence, causality and current treatment strategies of SAPF, b) comparative assessment of treatment strategies including or not including protein C supplementation c) identification of patient subgroups of particular eligibility for Protein C treatment, as judged by established criteria of disease severity assessment, d) feedback of aggregated data to registry contributors, thus permitting quality management and standard updates, e) dissemination of data evaluation summaries and recommendations for the use of Protein C formulations in clinical routine, f) elaboration of a framework for SAPF treatment recommendations and guidelines.

The registry comprises prospective, multicentric open-label data collection on the current state of incidence and management of SAPF, regardless of the etiopathogenic background. It will include comprehensive records on diagnosis, morbidity and management of SAPF, supplied in the form of electronic case report forms (eCRFs) by the participating centers over a period of three years.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Sepsis-Associated Purpura Fulminans International Registry - Europe
Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
Purpura fulminans
Patients diagnosed with Purpura fulminans in association with sepsis



Primary Outcome Measures :
  1. Mortality [ Time Frame: during hospital stay (estimated up to 3 months) ]
    All-cause in-hospital mortality assessed at day 1, day 3, day 5, and day 7, ICU and hospital discharge


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 7 days ]
    Changes in signs of organ dysfunction - sequential organ failure assessment score (SOFA), or paediatric logistic organ dysfunction scores (PELOD), at inclusion, day 1, day 3, day 5, and day 7

  2. Extent and severity of Purpura fulminans lesions [ Time Frame: 7 days ]
    Pictorial registration of localization (body parts) and severity (4 grades) of cutaneous lesions at intervals at inclusion, day 1, day 3, day 5, and day 7

  3. Purpura fulminans related surgery [ Time Frame: during hospital stay (estimated up to 3 months) ]
    Surgical interventions for irreversible purpura damage (debridement, fasciotomy, amputations)

  4. Invasive pathogen [ Time Frame: during hospital stay (estimated up to 3 months) ]
    Phenotyping of the microbial pathogen and definition of its antibiotic resistance, at hospital discharge

  5. Site of primary infection [ Time Frame: during hospital stay (estimated up to 3 months) ]
    Organ/system primarily affected by microbial infection, at hospital discharge

  6. Duration of ICU stay [ Time Frame: during ICU stay (estimated up to 3 months) ]
    Duration of hospitalization in an ICU

  7. Duration of hospital stay [ Time Frame: during hospital stay (estimated up to 3 months) ]
    Duration of hospitalization in an ICU

  8. Laboratory indices of organ dysfunction [ Time Frame: 7 days ]
    Plasma levels of glucose, lactate and creatine kinase inclusion, day 1, day 3, day 5, and day 7

  9. Inflammatory parameters [ Time Frame: 7 days ]
    Plasma concentrations of C-reactive protein, procalcitonin and interleukin-6 inclusion, day 1, day 3, day 5, and day 7

  10. Coagulation parameters [ Time Frame: 7 days ]
    Recording of plasma concentrations of prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, D-dimers, thrombin-antithrombin complex, protein C activity, antithrombin III activity inclusion, day 1, day 3, day 5, and day 7

  11. Hematological parameters [ Time Frame: 7 days ]
    Recording of white blood cell count (WBC) counts, platelet counts and hemoglobin levels at inclusion, day 1, day 3, day 5, and day 7

  12. Adverse drug reactions [ Time Frame: during hospital stay (estimated up to 3 months) ]
    Adverse Drug Reaction related to specific PF treatment (administration of anticoagulants/blood products) at hospital discharge


Other Outcome Measures:
  1. Antimicrobial therapy [ Time Frame: during ICU stay (estimated up to 3 months) ]
    Recording of type, dosis and duration of antibiotic use at inclusion, day 1, day 3, day 5, day 7, and ICU discharge

  2. Vasopressors [ Time Frame: during ICU stay (estimated up to 3 months) ]
    Cumulative doses of vasopressor drugs at inclusion, day 1, day 3, day 5, day 7, and at ICU discharge

  3. Blood products [ Time Frame: during ICU stay (estimated up to 3 months) ]
    Type and cumulative dose of blood products used (RBC, platelets), at day 1, day 3, day 5, day 7, and at ICU discharge

  4. Anticoagulant treatment [ Time Frame: during ICU stay (estimated up to 3 months) ]
    Type and cumulative dose of anticoagulant therapy at inclusion, day 1, day 3, day 5, and day , and ICU discharge

  5. Adjunctive therapy [ Time Frame: 7 days ]
    Type and cumulative doses of supportive therapy (corticoids, immunoglobulins, plasmapheresis, hemofiltration etc.)

  6. Duration of mechanical ventilation [ Time Frame: during ICU stay (estimated up to 3 months) ]
    Overall duration of use of mechanical ventilation (hours)

  7. Need of renal replacement therapy [ Time Frame: during ICU stay (estimated up to 3 months) ]
    Type and duration (hours) of renal replacement therapy at day 1, day 3, day 5, and day 7, and ICU discharge

  8. ECMO or other circulatory support systems [ Time Frame: during ICU stay (estimated up to 3 months) ]
    Use of ECMO or other circulatory support Systems, day 1, day 3, day 5, and day 7, and ICU discharge


Biospecimen Retention:   Samples Without DNA
Blood plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with sepsis-associated Purpura fulminans
Criteria

Inclusion Criteria:

  • Diagnosis of sepsis and Purpura fulminans
  • Signed informed consent

Exclusion Criteria:

  • Premature neonates (below gestational age of 36 weeks)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238795


Contacts
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Contact: Frank M Brunkhorst, MD +4936419323381 frank.brunkhorst@med.uni-jena.de
Contact: Jasmin Arrich, MD jasmin.arrich@med.uni-jena.de

Locations
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Germany
University Hospital Jena, Klinik für Anästhesiologie und Intensivmedizin Recruiting
Jena, Germany
Contact: Andreas Kortgen, PD Dr. med.         
University Hospital Jena, Klinik für Kinder- und Jugendmedizin Recruiting
Jena, Germany
Contact: Hans Proquitté, Prof.         
Klinikum der Universität München Recruiting
Munich, Germany, 80337
Contact: Martin Olivieri, MD    +49 89 4400 52811    martin.olivieri@med.uni-muenchen.de   
Sponsors and Collaborators
Jena University Hospital
Ludwig-Maximilians - University of Munich
Medical University of Vienna
University Hospital Tuebingen
University Hospital of Cologne
University Hospital, Essen
University Hospital Inselspital, Berne
Hannover Medical School
University Hospital, Basel, Switzerland
Evangelisches Krankenhaus Bielefeld gGmbH
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Study Chair: Frank M Brunkhorst, MD Center for Clinical Studies, Jena University Hospital

Additional Information:
Publications:
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Responsible Party: Jena University Hospital
ClinicalTrials.gov Identifier: NCT02238795     History of Changes
Other Study ID Numbers: ZKSJ0065
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jena University Hospital:
Purpura fulminans, Sepsis, Epidemiology, Morbidity, Therapy

Additional relevant MeSH terms:
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Sepsis
Toxemia
Purpura
Purpura Fulminans
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Skin Manifestations
Signs and Symptoms