Transfusion of Whole Blood in Acute Bleeding
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole blood transfusion.
- Who it may be relevant to
- Registry conditions: Blood Transfusion, Acute Bleeding. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transfusion av Helblod - Egenskaper Hos Produkten Och Effekt av Transfusion Hos Patienter
Overview
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.
Interventions
- Other Whole blood transfusion
Transfusion of whole blood in a situation with acute bleeding according to routine practice.
Primary outcome measures
- Mortality [Time frame: 30 day mortality]
- Effect of the whole blood transfusion on coagulation [Time frame: All transfusions occuring within 24 hours post transfusion of the whole blood unit]
- Bleeding [Time frame: All transfusions occuring within 24 hours post transfusion of the whole blood unit]
Secondary outcome measures (12)
- Hemolysis [Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30]
- Platelet count [Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30]
- Red blood cell count [Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30]
- APTT, a marker of coagulation capacity [Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
- PT, a marker of coagulation capacity [Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
- Anti-thrombin, a marker of coagulation capacity [Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
- Fibrinogen, a marker of of coagulation capacity [Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
- Electrolytes [Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
- Creatinine, a marker of of renal function [Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
- GFR, a marker of renal function [Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
- Urea, a measure of renal function [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 [Time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Örebro University — Örebro
Identifiers
NCT: NCT06019364 · 280695