Ireland
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Enrolling by invitation Observational

Transfusion of Whole Blood in Acute Bleeding

NCT06019364 · tracked via the Priya Life Science Sweden tracker
Sponsor
Sofia Ramström
Phase
Observational
Started
2023-09-10
Last updated
2023-11-01

Condition(s) studied

Blood TransfusionAcute Bleeding

Investigational drug(s) / intervention(s)

Whole blood transfusion

Whole blood transfusion: Transfusion of whole blood in a situation with acute bleeding according to routine practice.

Study summary

Blood collected from blood donors is routinely divided into its different components, red blood cells, plasma and platelets. These components are stored under different storage conditions and their maximum storage time before transfusion is different. Platelets are stored at a maximum of 7 days and at a temperature of 22°C to best preserve their function.

Research has been conduction on blood stored and transfused as whole blood (without separation into the various components), particularly in situations of acute trauma. Region Örebro län will therefore start transfusion of whole blood in such situations. The whole blood units will be stored at 4°C for a maximum of 14 days. This means that the platelets will be stored at a lower temperature than standard and for a longer time period. The research on how this will affect platelet function is limited.

This project aims to determine how the patients are affected regarding coagulation, hemolysis, renal function, immunisation, transfusion reactions and the effect of substances released from the blood cells in the whole blood units during the storage period and if there is an impact on mortality.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient with acute bleeding * Transfused with whole blood at the time of the acute bleeding episode Exclusion Criteria: * Patients where vital information lacking needed to interpret data (i.e. blood cell count)

Primary outcome measure(s)

  • Mortality — 30 day mortality
    Death within 30 days following the transfusion of whole blood
  • Effect of the whole blood transfusion on coagulation — All transfusions occuring within 24 hours post transfusion of the whole blood unit
    Requirement for other transfusions
  • Bleeding — All transfusions occuring within 24 hours post transfusion of the whole blood unit
    Bleeding following transfusion of the whole blood unit

Trial sites (1)

FacilityCityRegionStatus
Örebro University Örebro Sweden

More Sofia Ramström trials in Sweden

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06019364 on ClinicalTrials.gov ↗ ← All trials in Sweden