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RecruitingNCT06403163STARUpdated Sep 2, 2025

Transfusion Surveillance in Anaesthesia

An observational study in Transfusion Reaction, Transfusion Related Complication and Anesthesia, sponsored by Erasme University Hospital. Recruiting at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Erasme University Hospital · Observational

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Transfusion Reaction
  • Transfusion Related Complication
  • Anesthesia
  • Anesthesia; Shock
  • Side Effect
  • Fresh Blood Stool
  • Blood Coagulation Disorder
  • Blood Loss

Keywords

  • transfusion
  • monitoring
  • emergency situation
  • shock
  • fresh frozen plasma
03

In context

Transfusion Reaction

56 studies on the registry are indexed under Transfusion Reaction; 12 are open to participants now.

This study's planned enrollment of 50,000 is above the median of 387 across 26 observational studies indexed under Transfusion Reaction.

Browse Transfusion Reaction studies →

Lead sponsor

Erasme University Hospital is the lead sponsor of 181 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patient who received an hemostasis product during an hemorrhagic situation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all patients who have received an hemostasis product

Exclusion criteria

Exclusion Criteria:

  • patient who refused to consent to data analysis and study participation
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50,000 participants (estimated)
Target follow-up
2 Weeks
Patient registry
Yes

Groups and cohorts

  • Transfused patients

    patients who received an hemostatic product

    Procedure: Transfusion

Interventions

  • ProcedureTransfusion

    Transfusion of an hemostatic product

06

What researchers measure

Primary outcomes

  1. Hemostatic evolution through transfusion event

    evolution of APTT (seconds)

    Time frame: 12 hours

  2. ROTEM measures evolution through transfusion event

    evolution of APTEMCT (seconds)

    Time frame: 12 hours

  3. Haematologic measures evolution through transfusion event

    evolution of hemoglobin (g/dL)

    Time frame: 12 hours

  4. ionic measures evolution through transfusion event

    evolution of lactate (mmol/L)

    Time frame: 12 hours

Secondary outcomes

  1. Mortality at one month

    Mortality at one month

    Time frame: one month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06403163
Responsible party
Sponsor
First posted
May 7, 2024
Start date
Sep 1, 2022
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Sep 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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