Transfusion av Helblod - Egenskaper Hos Produkten Och Effekt av Transfusion Hos Patienter
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with acute bleeding
- •Transfused with whole blood at the time of the acute bleeding episode
排除标准
- •Patients where vital information lacking needed to interpret data (i.e. blood cell count)
结局指标
主要结局
Mortality
时间窗: 30 day mortality
Death within 30 days following the transfusion of whole blood
Effect of the whole blood transfusion on coagulation
时间窗: All transfusions occuring within 24 hours post transfusion of the whole blood unit
Requirement for other transfusions
Bleeding
时间窗: All transfusions occuring within 24 hours post transfusion of the whole blood unit
Bleeding following transfusion of the whole blood unit
次要结局
- Platelet count(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30)
- Red blood cell count(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30)
- APTT, a marker of coagulation capacity(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- PT, a marker of coagulation capacity(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- Anti-thrombin, a marker of coagulation capacity(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- Fibrinogen, a marker of of coagulation capacity(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- Electrolytes(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- Creatinine, a marker of of renal function(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- Hemolysis(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30)
- GFR, a marker of renal function(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- Urea, a measure of renal function(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- sP-selectin, a soluble marker of platelet activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- sGPVI, a soluble marker of platelet activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- PF4, a soluble marker of platelet activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- MMP9, a soluble marker of platelet activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- sCD40L, a soluble marker of platelet activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- sGPV, a soluble marker of platelet activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- SCUBE1, a soluble marker of platelet activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- sTNFR2, a marker of inflammation activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- RANTES, a bio modulating substance(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- IFN-gamma, a bio modulating substance(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- IL-7, a bio modulating substance(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- TSP1, a soluble marker of platelet activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- CRP, a marker of inflammation activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- sTNFR1, a marker of inflammation activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- D-dimer, a marker of coagulation activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- vWF, a marker of coagulation activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- TAT, a marker of coagulation activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- VEGF, a bio modulating substance(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- Serum amyloid A (SAA), a marker of inflammation activation(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- TNF-alfa, a bio modulating substance(Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30)
- Immunisation(Within 30 days post transfusion)
研究者
Sofia Ramström
Associated Professor
Örebro University, Sweden