Transfusion Surveillance in Anaesthesia (STAR)

August 25, 2025 updated by: Erasme University Hospital

Biological Transfusion Efficiency Registry Transfusion Surveillance in Anaesthesia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Université libre de Bruxelles
        • Contact:
        • Principal Investigator:
          • Olivier DURANTEAU, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patient who received an hemostasis product during an hemorrhagic situation

Description

Inclusion Criteria:

  • all patients who have received an hemostasis product

Exclusion Criteria:

  • patient who refused to consent to data analysis and study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transfused patients
patients who received an hemostatic product
Procedure: Transfusion
Transfusion of an hemostatic product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemostatic evolution through transfusion event
Time Frame: 12 hours
evolution of APTT (seconds)
12 hours
ROTEM measures evolution through transfusion event
Time Frame: 12 hours
evolution of APTEMCT (seconds)
12 hours
Haematologic measures evolution through transfusion event
Time Frame: 12 hours
evolution of hemoglobin (g/dL)
12 hours
ionic measures evolution through transfusion event
Time Frame: 12 hours
evolution of lactate (mmol/L)
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at one month
Time Frame: one month
Mortality at one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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