Anesthesia Clinical Trial
— STAROfficial title:
Biological Transfusion Efficiency Registry Transfusion Surveillance in Anaesthesia
NCT number | NCT06403163 |
Other study ID # | STAR |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2022 |
Est. completion date | December 31, 2030 |
Verified date | April 2024 |
Source | Erasme University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Recruiting |
Enrollment | 50000 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - all patients who have received an hemostasis product Exclusion Criteria: - patient who refused to consent to data analysis and study participation |
Country | Name | City | State |
---|---|---|---|
Belgium | Université libre de Bruxelles | Anderlecht |
Lead Sponsor | Collaborator |
---|---|
Erasme University Hospital |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemostatic evolution through transfusion event | evolution of APTT (seconds) | 12 hours | |
Primary | ROTEM measures evolution through transfusion event | evolution of APTEMCT (seconds) | 12 hours | |
Primary | Haematologic measures evolution through transfusion event | evolution of hemoglobin (g/dL) | 12 hours | |
Primary | ionic measures evolution through transfusion event | evolution of lactate (mmol/L) | 12 hours | |
Secondary | Mortality at one month | Mortality at one month | one month |
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