Storage Temperature and Quality of Leucoreduced Whole Blood
NCT ID: NCT01892670
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2013-03-31
2016-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Filtered whole blood
Leukocyte-reduced whole blood, 2 hours holding-time after collection. Gravitational filtration.
Device: Terumo IMUFLEX WB(Whole blood)-SP(saving platelets) collection bag system
Donation of 1 whole blood unit
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
Unfiltered whole blood
Non-leukocyte-reduced whole blood, 2 hours holding-time after collection.
Device: Terumo IMUFLEX WB-SP collection bag system
Donation of 1 whole blood unit
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
Warm-filtered whole blood
Leukocyte-reduced whole blood, no holding-time after collection. Gravitational filtration.
Device: Terumo IMUFLEX WB-SP collection bag system
Donation of 1 whole blood unit
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
Forced warm-filtration of whole bood
Leukocyte-reduced whole blood, no holding-time after collection. Forced filtration.
Device: Terumo IMUFLEX WB-SP collection bag system
Donation of 1 whole blood unit
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
RCC produced from cold-stored whole blood
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.
Donation of 1 whole blood unit
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
RCC produced from cold-stored non-filtered whole blood
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.
Donation of 1 whole blood unit
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
Interventions
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Donation of 1 whole blood unit
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Mild flu or more severe illnesses
* Open wound
* Pregnancy or trying to get pregnant
18 Years
70 Years
ALL
Yes
Sponsors
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Norwegian Armed Forces Medical Service
OTHER_GOV
Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Geir Strandenes, MD
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital and Norwegian Naval Special Operation Commando
Locations
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Haukeland University Hospital, Dept of Immunology and Transfusion Medicine
Bergen, , Norway
Countries
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Related Links
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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
Other Identifiers
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2012/2279
Identifier Type: -
Identifier Source: org_study_id
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