NCT06403163

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Sep 2022Dec 2030

First Submitted

Initial submission to the registry

February 8, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

8.3 years

First QC Date

February 8, 2022

Last Update Submit

August 25, 2025

Conditions

Transfusion ReactionTransfusion Related ComplicationAnesthesiaAnesthesia; ShockSide EffectFresh Blood StoolBlood Coagulation DisorderBlood Loss

Keywords

transfusionmonitoringemergency situationshockfresh frozen plasma

Outcome Measures

Primary Outcomes (4)

  • 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 (1)

  • Mortality at one month

    one month

Study Arms (1)

Transfused patients

patients who received an hemostatic product

Procedure: Transfusion

Interventions

TransfusionPROCEDURE

Transfusion of an hemostatic product

Transfused patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patient who received an hemostasis product during an hemorrhagic situation

You may qualify if:

  • all patients who have received an hemostasis product

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université libre de Bruxelles

Anderlecht, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Transfusion ReactionShockGastrointestinal HemorrhageBlood Coagulation DisordersHemorrhageEmergencies

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal DiseasesDigestive System DiseasesDisease Attributes

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2022

First Posted

May 7, 2024

Study Start

September 1, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)