Transfusion of Whole Blood in Acute Bleeding

Blood Transfusion Clinical Trial

— HEPEP  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06019364
• Other study ID #: 280695
• Status: Enrolling by invitation
• Start date: September 10, 2023
• Est. completion date: August 1, 2031

Study information

• Verified date: October 2023
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: August 1, 2031
• Est. primary completion date: August 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Bleeding
• Blood Transfusion
• Hemorrhage

Intervention

Other:
• Whole blood transfusion
Transfusion of whole blood in a situation with acute bleeding according to routine practice.

Locations

Country	Name	City	State
Sweden	Örebro University	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Sofia Ramström

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death within 30 days following the transfusion of whole blood	30 day mortality
Primary	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
Primary	Bleeding	Bleeding following transfusion of the whole blood unit	All transfusions occuring within 24 hours post transfusion of the whole blood unit
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Immunisation	Occurence of immunisation following transfusion of the whole blood	Within 30 days post transfusion