Characterising the Loss of Haemostasis in Haemorrhagic Fever With Renal Syndrome

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLiverpool School of Tropical Medicine

About this trial

Hantaviruses are globally distributed viruses that cause haemorrhagic fever with renal syndrome (HFRS) in Europe, a disease characterised by acute kidney failure and, in some cases, significant bleeding complications. The mechanisms underlying clotting abnormalities in HFRS remain poorly understood. This study aims to investigate the pathological mechanisms of clotting dysfunction in hospitalised HFRS patients, assess the impact of different hantavirus types on disease severity, and evaluate the accuracy of a severity scoring system developed in China for predicting mortality in European patients.

Hospitalised patients with laboratory-confirmed HFRS will be prospectively recruited from University Medical Centre Ljubljana, Slovenia. Blood samples will be analysed for routine laboratory markers, thromboelastography (TEG) will assess real-time clotting function, and transcriptomic analysis will identify hantavirus strains and gene expression patterns linked to disease severity. Patients will be stratified into haemorrhagic and non-haemorrhagic groups, with statistical analyses comparing clinical and laboratory parameters to identify predictors of bleeding risk. Findings from this study may contribute to improved risk stratification and potential therapeutic targets for HFRS.

Eligibility criteria

Qualifiers

Patients aged 18 or older, including pregnant women

Laboratory-confirmed HFRS (serology and/or RT-PCR)

Willing and able to provide informed consent

Disqualifiers

Patients under 18 years of age

Co-infections with other pathogens

Pre-existing coagulation disorders

Use of anticoagulant medication

Trial design

Treatments tested in this trial

  • Blood draw for thromboelastography - admission
  • Blood draw for thromboelastography - follow-up
  • Blood draw for transcriptomic analysis
  • Data collection - clinical/demographic/epidemiological data
  • Data collection - routine laboratory parameters
  • Severity score calculation

Treatment groups

62 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Liverpool School of Tropical Medicine

Lead sponsor

Institute of microbiology and immunology, Slovenia

Collaborator