Characterising the Loss of Haemostasis in Haemorrhagic Fever With Renal Syndrome

Not yet recruitingOBSERVATIONAL
Enrollment

62

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

August 31, 2027

Conditions
Haemorrhagic Fever With Renal Syndrome
Interventions
PROCEDURE

Blood draw for thromboelastography - admission

Two blood samples will be collected at admission for thromboelastography using the TEG 6s platform (Haemonetics®). One sample will be collected in a citrated blood tube for global haemostasis assessment, and one sample will be collected in a heparinised tube for platelet function analysis.

PROCEDURE

Blood draw for thromboelastography - follow-up

Two blood samples will be collected 3 - 7 days after initial thromboelastography for follow-up analysis using the TEG 6s platform (Haemonetics®). One sample will be collected in a citrated blood tube for global haemostasis assessment, and one sample will be collected in a heparinised tube for platelet function analysis.

PROCEDURE

Blood draw for transcriptomic analysis

One blood sample will be collected at admission for transcriptomic analysis. Blood sample will be collected into a PAXgene® RNA tube and analysed using nanopore sequencing to characterise the viral and host transcriptome.

OTHER

Data collection - clinical/demographic/epidemiological data

Routine clinical/demographic/epidemiological data will be collected at admission and throughout hospitalisation. This will relate to clinical presentation (day of illness at presentation, presenting symptoms); demographics and epidemiology (age, gender, site of infection); clinical course during hospitalisation (maximum level of care, dialysis use, blood product use, survival outcome).

OTHER

Data collection - routine laboratory parameters

Data on routine laboratory parameters will be collected throughout hospitalisation. These will relate to laboratory clotting parameters (platelet count, prothrombin time, activated partial thromboplastin time, fibrinogen, D-dimer); liver function tests (aspartate aminotransferase, alanine aminotransferase); laboratory haematology parameters (haemoglobin, white cell count, blood film); laboratory biochemistry parameters (urea, creatinine); viral load.

OTHER

Severity score calculation

A severity score will be assigned to each patient based on clinical and laboratory data at admission according to a pre-defined scoring system.

All Listed Sponsors
collaborator

Institute of microbiology and immunology, Slovenia

UNKNOWN

lead

Liverpool School of Tropical Medicine

OTHER

NCT06944275 - Characterising the Loss of Haemostasis in Haemorrhagic Fever With Renal Syndrome | Biotech Hunter | Biotech Hunter