Storage Temperature and Quality of Leucoreduced Whole Blood

Study Overview
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Brief Summary
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In a combat situation the need for safe and high-quality blood products is increasing. WB (Whole Blood) is used in many trauma situations, but we wish to investigate whether there is an even better whole blood product. The purpose of this study is to examine the quality of leucoreduced, cold-stored whole blood. We also wish to examine the effects of filtration of whole blood without a 1-2 hour holding-time (warm-filtration) and the effects of forced filtration. We also wish to explore the possibility of using cold-stored WB for production of RCC. Analyses are performed with a main focus to investigate function and quality of red blood cells and platelets.

Official Title
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Storage Temperature and Quality of Leucoreduced Whole Blood

Conditions
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Trauma, Austere Environment, Blood Bank, Buddy Transfusion

Intervention / Treatment
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* Other: Donation of 1 whole blood unit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer Age between 18 and 70 Negative pregnancy test (women in fertile age) Blood pressure range: (160-100)/(100-40) Pulse range: 40-100 Exclusion Criteria: Usage of platelet-influencing medication Mild flu or more severe illnesses Open wound Pregnancy or trying to get pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Filtered whole blood<br>Leukocyte-reduced whole blood, 2 hours holding-time after collection. Gravitational filtration. Device: Terumo IMUFLEX WB(Whole blood)-SP(saving platelets) collection bag system | Other: Donation of 1 whole blood unit<br>* Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.<br>* Other names: Terumo IMUFLEX WB-SP collection bag system.;|
| Experimental: Unfiltered whole blood<br>Non-leukocyte-reduced whole blood, 2 hours holding-time after collection. Device: Terumo IMUFLEX WB-SP collection bag system | Other: Donation of 1 whole blood unit<br>* Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.<br>* Other names: Terumo IMUFLEX WB-SP collection bag system.;|
| Experimental: Warm-filtered whole blood<br>Leukocyte-reduced whole blood, no holding-time after collection. Gravitational filtration. Device: Terumo IMUFLEX WB-SP collection bag system | Other: Donation of 1 whole blood unit<br>* Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.<br>* Other names: Terumo IMUFLEX WB-SP collection bag system.;|
| Experimental: Forced warm-filtration of whole bood<br>Leukocyte-reduced whole blood, no holding-time after collection. Forced filtration. Device: Terumo IMUFLEX WB-SP collection bag system | Other: Donation of 1 whole blood unit<br>* Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.<br>* Other names: Terumo IMUFLEX WB-SP collection bag system.;|
| Experimental: RCC produced from cold-stored whole blood<br>RCC production from 7 days old, cold-stored, leukocyte-reduced whole blood. Units stored for another 35 days. (42 days of storage in total). Devices: Terumo IMUFLEX WB-SP/WB-RP collection bag systems. | Other: Donation of 1 whole blood unit<br>* Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.<br>* Other names: Terumo IMUFLEX WB-SP collection bag system.;|
| Experimental: RCC produced from cold-stored non-filtered whole blood<br>RCC production from 7 days old, cold-stored, non-leukocyte-reduced whole blood. Units stored for another 35 days. (42 days of storage in total). Devices: Terumo IMUFLEX WB-SP/WB-RP(removing platelets) collection bag systems. | Other: Donation of 1 whole blood unit<br>* Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.<br>* Other names: Terumo IMUFLEX WB-SP collection bag system.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet function | Platelet function is assessed by various parameters, such as thrombelastography (TEG), Multiplate and flow cytometry (Lactadherin, Calcein violet AM, ++). | After 10 days of cold-storage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte count | Filtered whole blood should have a concentration less than 1*10^6 cells/L to avoid transfusion reactions. | After leukocyte filtration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood, Whole blood, Cold-storage, Filtration, Transfusion, Platelet-function