HEPEP: Transfusion of Whole Blood in Acute Bleeding
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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
Secondary Outcome Measures
- Hemolysis [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30]
Hemolysis at various time points in conjunction to the whole blood transfusion
- Platelet count [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30]
Platelet count at various time points in conjunction to the whole blood transfusion
- Red blood cell count [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30]
Red blood cell count at various time points in conjunction to the whole blood transfusion
- APTT, a marker of coagulation capacity [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of APTT at various time points in conjunction to the whole blood transfusion
- PT, a marker of coagulation capacity [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of PT at various time points in conjunction to the whole blood transfusion
- Anti-thrombin, a marker of coagulation capacity [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of anti-thrombin at various time points in conjunction to the whole blood transfusion
- Fibrinogen, a marker of of coagulation capacity [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of fibrinogen at various time points in conjunction to the whole blood transfusion
- Electrolytes [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Electrolytes at various time points in conjunction to the whole blood transfusion
- Creatinine, a marker of of renal function [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of Creatinine at various time points in conjunction to the whole blood transfusion
- GFR, a marker of renal function [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of GFR at various time points in conjunction to the whole blood transfusion
- Urea, a measure of renal function [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of urea at various time points in conjunction to the whole blood transfusion
- sP-selectin, a soluble marker of platelet activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of sP-selectin at various time points in conjunction to the whole blood transfusion
- PF4, a soluble marker of platelet activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of PF4 at various time points in conjunction to the whole blood transfusion
- MMP9, a soluble marker of platelet activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of MMP9 at various time points in conjunction to the whole blood transfusion
- sCD40L, a soluble marker of platelet activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of sCD40L at various time points in conjunction to the whole blood transfusion
- sGPV, a soluble marker of platelet activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of sGPV at various time points in conjunction to the whole blood transfusion
- sGPVI, a soluble marker of platelet activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of sGPVI at various time points in conjunction to the whole blood transfusion
- SCUBE1, a soluble marker of platelet activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of SCUBE1 at various time points in conjunction to the whole blood transfusion
- TSP1, a soluble marker of platelet activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of TSP1 at various time points in conjunction to the whole blood transfusion
- CRP, a marker of inflammation activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of CRP at various time points in conjunction to the whole blood transfusion
- Serum amyloid A (SAA), a marker of inflammation activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of Serum amyloid A at various time points in conjunction to the whole blood transfusion
- sTNFR1, a marker of inflammation activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of sTNFR1 at various time points in conjunction to the whole blood transfusion
- sTNFR2, a marker of inflammation activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of sTNFR2 at various time points in conjunction to the whole blood transfusion
- D-dimer, a marker of coagulation activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of D-dimer at various time points in conjunction to the whole blood transfusion
- vWF, a marker of coagulation activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of vWF at various time points in conjunction to the whole blood transfusion
- TAT, a marker of coagulation activation [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of TAT at various time points in conjunction to the whole blood transfusion
- RANTES, a bio modulating substance [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of RANTES at various time points in conjunction to the whole blood transfusion
- VEGF, a bio modulating substance [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of VEGF at various time points in conjunction to the whole blood transfusion
- IFN-gamma, a bio modulating substance [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of IFN-gamma at various time points in conjunction to the whole blood transfusion
- TNF-alfa, a bio modulating substance [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of TNF-alfa at various time points in conjunction to the whole blood transfusion
- IL-7, a bio modulating substance [Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
Analysis of IL-7 at various time points in conjunction to the whole blood transfusion
- Immunisation [Within 30 days post transfusion]
Occurence of immunisation following transfusion of the whole blood
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Örebro University | Örebro | Sweden | 70182 |
Sponsors and Collaborators
- Sofia Ramström
Investigators
- Principal Investigator: Sofia Ramström, Ass. Prof, Örebro University, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 280695