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| Name | Class |
|---|---|
| Norwegian Armed Forces Medical Service | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filtered whole blood | Experimental | Leukocyte-reduced whole blood, 2 hours holding-time after collection. Gravitational filtration. Device: Terumo IMUFLEX WB(Whole blood)-SP(saving platelets) collection bag system |
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| Unfiltered whole blood | Experimental | Non-leukocyte-reduced whole blood, 2 hours holding-time after collection. Device: Terumo IMUFLEX WB-SP collection bag system |
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| Warm-filtered whole blood | Experimental | Leukocyte-reduced whole blood, no holding-time after collection. Gravitational filtration. Device: Terumo IMUFLEX WB-SP collection bag system |
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| Forced warm-filtration of whole bood | Experimental | Leukocyte-reduced whole blood, no holding-time after collection. Forced filtration. Device: Terumo IMUFLEX WB-SP collection bag system |
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| RCC produced from cold-stored whole blood | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donation of 1 whole blood unit | Other | Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines. |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemolysis | RCC should not have a hemolysis of more than 0.8 %. We investigate this up to 42 days (35 days as RCC) (arm 5 +6) | After 42 days of storage |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geir Strandenes, MD | Haukeland University Hospital and Norwegian Naval Special Operation Commando | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital, Dept of Immunology and Transfusion Medicine | Bergen | 5021 | Norway |
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| Label | URL |
|---|---|
| THOR: Trauma Hemostasis and Oxygenation Research Network. Main objective: To reduce the risk of death from traumatic hemorrhagic shock prior to admission at a trauma center | View source |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| RCC produced from cold-stored non-filtered whole blood | Experimental | 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. |
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