Transfusion ReactionSTARNCT06403163
Transfusion Surveillance in Anaesthesia
An observational study of Transfusion Reaction and Transfusion Related Complication, run by Erasme University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transfusion Reaction, Transfusion Related Complication, Anesthesia
- What is being tested?
- Transfusion
- Type of treatment
- Surgery or procedure
- How many people
- 50,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2022to 31 Dec 2030
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patient who received an hemostasis product during an hemorrhagic situation
Who may be able to join
- all patients who have received an hemostasis product
Who cannot join
- patient who refused to consent to data analysis and study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Université libre de Bruxelles
Anderlecht, 1070
Oliver Duranteau, M.D., +3225553919, olivier.duranteau@erasme.ulb.ac.be
Olivier DURANTEAU, M.D.
About this study
Official title: 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.
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.
- Conditions
- Transfusion Reaction, Transfusion Related Complication, Anesthesia, Anesthesia; Shock, Side Effect, Fresh Blood Stool
- Being tested
- Transfusion
- Keywords
- transfusion, monitoring, emergency situation, shock, fresh frozen plasma
- Medical subject headings
- Transfusion Reaction, Shock, Gastrointestinal Hemorrhage, Blood Coagulation Disorders, Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransfusionProcedure or surgery
Transfusion of an hemostatic product
| Study group | Role | What they receive |
|---|---|---|
| Transfused patients | patients who received an hemostatic product Receives: Procedure: Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostatic evolution through transfusion event
evolution of APTT (seconds)
Measured: 12 hours
ROTEM measures evolution through transfusion event
evolution of APTEMCT (seconds)
Measured: 12 hours
Haematologic measures evolution through transfusion event
evolution of hemoglobin (g/dL)
Measured: 12 hours
ionic measures evolution through transfusion event
evolution of lactate (mmol/L)
Measured: 12 hours
Secondary outcomes (1)
Mortality at one month
Mortality at one month
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Sep 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403163
- Sponsor's protocol ID
- STAR
- Acronym
- STAR
- Status last verified
- Aug 2025
- First submitted
- 8 Feb 2022
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Transfusion Efficiency Registry Transfusion Surveillance in Anaesthesia
- ClinicalTrials.gov ID
- NCT06403163
- Acronym / sponsor ID
- STAR / STAR
- Conditions
- Transfusion Reaction, Transfusion Related Complication, Anesthesia, Anesthesia; Shock, Side Effect, Fresh Blood Stool
- Keywords
- transfusion, monitoring, emergency situation, shock, fresh frozen plasma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transfused patients | – | Procedure: Transfusionpatients who received an hemostatic product |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient who received an hemostasis product during an hemorrhagic situation
Key inclusion criteria (1 listed)
- all patients who have received an hemostasis product
Key exclusion criteria (1 listed)
- patient who refused to consent to data analysis and study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TransfusionTransfusion of an hemostatic product | Procedure or surgery | Transfused patients |
Primary outcome
Hemostatic evolution through transfusion event
Time frame: 12 hours
evolution of APTT (seconds)
ROTEM measures evolution through transfusion event
Time frame: 12 hours
evolution of APTEMCT (seconds)
Haematologic measures evolution through transfusion event
Time frame: 12 hours
evolution of hemoglobin (g/dL)
ionic measures evolution through transfusion event
Time frame: 12 hours
evolution of lactate (mmol/L)
1 secondary outcome
Mortality at one month
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transfusion Reaction and Transfusion Related Complication, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostatic evolution through transfusion event (time frame: 12 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.