Clinical trial NCT06019364: Transfusion of Whole Blood in Acute Bleeding
Official title: Transfusion av Helblod - Egenskaper Hos Produkten Och Effekt av Transfusion Hos Patienter
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Blood Transfusion
Acute Bleeding
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with acute bleeding that are transfused with whole blood at the time of the acute bleeding episode.

Brief 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.

Detailed description: 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.

Platelets function is to contribute to the formation of a clot to stop and prevent bleeding. Previous studies has shown that this might be affected if they are stored refrigerated. Exactly how they are affected is not known and when this occurs during the storage period.

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.

Since transfusion of refrigerated whole blood is a new procedure 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.

Patients requiring transfusion with a whole blood due to an acute situation with bleeding will be enrolled. Blood samples will be taken from the patients for analysis directly before the transfusion and at various time points after the transfusion. Clinical variables of importance to interpret the effect of the whole blood transfusion will be registered as well as basic information such as sex, age, height, weight, blood group and type of injury causing the bleeding, treatment etc.

Eligibility criteria: 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 outcomes:
measure: Mortality
timeFrame: 30 day mortality
measure: Effect of the whole blood transfusion on coagulation
timeFrame: All transfusions occuring within 24 hours post transfusion of the whole blood unit
measure: Bleeding
timeFrame: All transfusions occuring within 24 hours post transfusion of the whole blood unit
Secondary outcomes:
measure: Hemolysis
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30
measure: Platelet count
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30
measure: Red blood cell count
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30
measure: APTT, a marker of coagulation capacity
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: PT, a marker of coagulation capacity
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: Anti-thrombin, a marker of coagulation capacity
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: Fibrinogen, a marker of of coagulation capacity
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: Electrolytes
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: Creatinine, a marker of of renal function
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: GFR, a marker of renal function
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: Urea, a measure of renal function
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: sP-selectin, a soluble marker of platelet activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: PF4, a soluble marker of platelet activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: MMP9, a soluble marker of platelet activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: sCD40L, a soluble marker of platelet activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: sGPV, a soluble marker of platelet activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: sGPVI, a soluble marker of platelet activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: SCUBE1, a soluble marker of platelet activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: TSP1, a soluble marker of platelet activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: CRP, a marker of inflammation activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: Serum amyloid A (SAA), a marker of inflammation activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: sTNFR1, a marker of inflammation activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: sTNFR2, a marker of inflammation activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: D-dimer, a marker of coagulation activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: vWF, a marker of coagulation activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: TAT, a marker of coagulation activation
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: RANTES, a bio modulating substance
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: VEGF, a bio modulating substance
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: IFN-gamma, a bio modulating substance
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: TNF-alfa, a bio modulating substance
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: IL-7, a bio modulating substance
timeFrame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
measure: Immunisation
timeFrame: Within 30 days post transfusion
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
affiliation: Örebro University, Sweden
name: Sofia Ramström, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References: