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NCT06403163 Clinical Trial

Transfusion Surveillance in Anaesthesia

Anesthesia Clinical Trial

— STAR  

Official title:
Biological Transfusion Efficiency Registry Transfusion Surveillance in Anaesthesia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06403163
Other study ID # STAR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date December 31, 2030

Study information
Verified date April 2024
Source Erasme University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage. The aim is to allow different modelling and analysis related to emergency transfusion.

Description:

the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage. The aim is to allow different modelling and analysis related to emergency transfusion. Patients will be informed at the time of the anaesthesia consultation about the inclusion in the registry. The data will be collected from the patients' files by the investigators of the centre without modifying their management. The data collection period will not exceed the period of acute management.

Recruitment information / eligibility
Status Recruiting
Enrollment 50000
Est. completion date December 31, 2030
Est. primary completion date December 31, 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - all patients who have received an hemostasis product Exclusion Criteria: - patient who refused to consent to data analysis and study participation

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Transfusion
Transfusion of an hemostatic product

Locations
Country Name City State
Belgium Université libre de Bruxelles Anderlecht

Sponsors (1)
Lead Sponsor Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemostatic evolution through transfusion event evolution of APTT (seconds) 12 hours
Primary ROTEM measures evolution through transfusion event evolution of APTEMCT (seconds) 12 hours
Primary Haematologic measures evolution through transfusion event evolution of hemoglobin (g/dL) 12 hours
Primary ionic measures evolution through transfusion event evolution of lactate (mmol/L) 12 hours
Secondary Mortality at one month Mortality at one month one month
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