Clinical Trial

Characterising the Loss of Haemostasis in Haemorrhagic Fever With Renal Syndrome

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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-23.
Trial Details
NCT Number NCT06944275
Lead Sponsor Liverpool School of Tropical Medicine
Collaborators: Institute of microbiology and immunology, Slovenia
Conditions Haemorrhagic Fever With Renal Syndrome
Enrollment 62 participants
Start Date 2026-05-01
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-19