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Enrolling by Invitation

NCT Number: NCT06019364

Transfusion of Whole Blood in Acute Bleeding

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.

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Key information

Conditions

Blood Transfusion Acute Bleeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Örebro University

Örebro, 70182, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Whole blood transfusion

Other

Transfusion of whole blood in a situation with acute bleeding according to routine practice.

Primary outcomes

  1. Mortality

    Time frame: 30 day mortality

    Death within 30 days following the transfusion of whole blood

  2. Effect of the whole blood transfusion on coagulation

    Time frame: All transfusions occuring within 24 hours post transfusion of the whole blood unit

    Requirement for other transfusions

  3. Bleeding

    Time frame: All transfusions occuring within 24 hours post transfusion of the whole blood unit

    Bleeding following transfusion of the whole blood unit

Secondary outcomes

  1. Hemolysis

    Time frame: 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

  2. Platelet count

    Time frame: 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

  3. Red blood cell count

    Time frame: 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

  4. APTT, a marker of coagulation capacity

    Time frame: 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

  5. PT, a marker of coagulation capacity

    Time frame: 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

  6. Anti-thrombin, a marker of coagulation capacity

    Time frame: 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

  7. Fibrinogen, a marker of of coagulation capacity

    Time frame: 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

  8. Electrolytes

    Time frame: 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

  9. Creatinine, a marker of of renal function

    Time frame: 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

  10. GFR, a marker of renal function

    Time frame: 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

  11. Urea, a measure of renal function

    Time frame: 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

  12. 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

    Analysis of sP-selectin at various time points in conjunction to the whole blood transfusion

  13. PF4, a soluble marker of platelet activation

    Time frame: 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

  14. MMP9, a soluble marker of platelet activation

    Time frame: 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

  15. sCD40L, a soluble marker of platelet activation

    Time frame: 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

  16. sGPV, a soluble marker of platelet activation

    Time frame: 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

  17. sGPVI, a soluble marker of platelet activation

    Time frame: 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

  18. SCUBE1, a soluble marker of platelet activation

    Time frame: 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

  19. TSP1, a soluble marker of platelet activation

    Time frame: 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

  20. CRP, a marker of inflammation activation

    Time frame: 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

  21. Serum amyloid A (SAA), a marker of inflammation activation

    Time frame: 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

  22. sTNFR1, a marker of inflammation activation

    Time frame: 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

  23. sTNFR2, a marker of inflammation activation

    Time frame: 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

  24. D-dimer, a marker of coagulation activation

    Time frame: 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

  25. vWF, a marker of coagulation activation

    Time frame: 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

  26. TAT, a marker of coagulation activation

    Time frame: 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

  27. RANTES, a bio modulating substance

    Time frame: 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

  28. VEGF, a bio modulating substance

    Time frame: 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

  29. IFN-gamma, a bio modulating substance

    Time frame: 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

  30. TNF-alfa, a bio modulating substance

    Time frame: 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

  31. IL-7, a bio modulating substance

    Time frame: 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

  32. Immunisation

    Time frame: Within 30 days post transfusion

    Occurence of immunisation following transfusion of the whole blood

Sponsors and collaborators

Lead sponsor

Sofia Ramström

Other

Registry information

Official study title

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

Acronym: HEPEP

Important dates

Study start
2023
Primary completion
2030
Study completion
2031
First posted
Aug 31, 2023
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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