Transfusion Surveillance in Anaesthesia | NCT06403163

Studies
Transfusion Surveillance in Anaesthesia

NCT06403163

Sponsor

Erasme University Hospital

Status

Recruiting

Last Update Posted

Sep 2, 2025Actual

Enrollment

50,000Estimated

Phase

Not provided

Conditions

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

Interventions

Transfusion

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Feb 8, 2022

First Submission Date that Met QC Criteria

May 6, 2024

First Posted Date

May 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2025

Last Update Posted Date

Sep 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transfused patients		patients who received an hemostatic product	Procedure: Transfusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transfusion	Procedure	Transfusion of an hemostatic product	Transfused patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients who have received an hemostasis product

Exclusion Criteria:

patient who refused to consent to data analysis and study participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patient who received an hemostasis product during an hemorrhagic situation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Université libre de Bruxelles	Recruiting	Anderlecht		1070	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065227	Transfusion Reaction
D012769	Shock
D006471	Gastrointestinal Hemorrhage
D001778	Blood Coagulation Disorders
D006470	Hemorrhage
D004630	Emergencies

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007154	Immune System Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001803	Blood Transfusion

Ancestor Terms

ID	Term
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided