An observational study in Blood Transfusion and Acute Bleeding, sponsored by Sofia Ramström. Enrolling by invitation at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Sofia Ramström · Observational
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.
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 893 observational studies indexed under Hemorrhage.
Browse Hemorrhage studies →Sofia Ramström is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with acute bleeding that are transfused with whole blood at the time of the acute bleeding episode.
Exclusion Criteria:
Transfusion of whole blood in a situation with acute bleeding according to routine practice.
Mortality
Death within 30 days following the transfusion of whole blood
Time frame: 30 day mortality
Effect of the whole blood transfusion on coagulation
Requirement for other transfusions
Time frame: All transfusions occuring within 24 hours post transfusion of the whole blood unit
Bleeding
Bleeding following transfusion of the whole blood unit
Time frame: All transfusions occuring within 24 hours post transfusion of the whole blood unit
Hemolysis
Hemolysis at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30
Platelet count
Platelet count at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30
Red blood cell count
Red blood cell count at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30
APTT, a marker of coagulation capacity
Analysis of APTT at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
PT, a marker of coagulation capacity
Analysis of PT at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
Anti-thrombin, a marker of coagulation capacity
Analysis of anti-thrombin at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
Fibrinogen, a marker of of coagulation capacity
Analysis of fibrinogen at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
Electrolytes
Electrolytes at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
Creatinine, a marker of of renal function
Analysis of Creatinine at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
GFR, a marker of renal function
Analysis of GFR at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
Urea, a measure of renal function
Analysis of urea at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
sP-selectin, a soluble marker of platelet activation
Analysis of sP-selectin at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
PF4, a soluble marker of platelet activation
Analysis of PF4 at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
MMP9, a soluble marker of platelet activation
Analysis of MMP9 at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
sCD40L, a soluble marker of platelet activation
Analysis of sCD40L at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
sGPV, a soluble marker of platelet activation
Analysis of sGPV at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
sGPVI, a soluble marker of platelet activation
Analysis of sGPVI at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
SCUBE1, a soluble marker of platelet activation
Analysis of SCUBE1 at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
TSP1, a soluble marker of platelet activation
Analysis of TSP1 at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
CRP, a marker of inflammation activation
Analysis of CRP at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
Serum amyloid A (SAA), a marker of inflammation activation
Analysis of Serum amyloid A at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
sTNFR1, a marker of inflammation activation
Analysis of sTNFR1 at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
sTNFR2, a marker of inflammation activation
Analysis of sTNFR2 at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
D-dimer, a marker of coagulation activation
Analysis of D-dimer at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
vWF, a marker of coagulation activation
Analysis of vWF at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
TAT, a marker of coagulation activation
Analysis of TAT at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
RANTES, a bio modulating substance
Analysis of RANTES at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
VEGF, a bio modulating substance
Analysis of VEGF at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
IFN-gamma, a bio modulating substance
Analysis of IFN-gamma at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
TNF-alfa, a bio modulating substance
Analysis of TNF-alfa at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
IL-7, a bio modulating substance
Analysis of IL-7 at various time points in conjunction to the whole blood transfusion
Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
Immunisation
Occurence of immunisation following transfusion of the whole blood
Time frame: Within 30 days post transfusion
Plan to share: No
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Sofia Ramström