Transfusion of Whole Blood in Acute Bleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transfusion av Helblod - Egenskaper Hos Produkten Och Effekt av Transfusion Hos Patienter

Conditions
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Blood Transfusion, Acute Bleeding

Intervention / Treatment
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* Other: Whole blood transfusion


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Whole blood transfusion|Transfusion of whole blood in a situation with acute bleeding according to routine practice.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death within 30 days following the transfusion of whole blood | 30 day mortality | 
| Effect of the whole blood transfusion on coagulation | Requirement for other transfusions | All transfusions occuring within 24 hours post transfusion of the whole blood unit | 
| Bleeding | Bleeding following transfusion of the whole blood unit | All transfusions occuring within 24 hours post transfusion of the whole blood unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemolysis | Hemolysis at various time points in conjunction to the whole blood transfusion | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Within 30 days post transfusion |