Transfusion of Whole Blood in Acute Bleeding (HEPEP)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Blood Transfusion; Acute Bleeding
• Intervention / Treatment: Other: Whole blood transfusion

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70182
    • Örebro University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient with acute bleeding that are transfused with whole blood at the time of the acute bleeding episode.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sofia Ramström
• Investigators: Principal Investigator: Sofia Ramström, Ass. Prof, Örebro University, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2023
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 280695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No