NCT01892670|Completed
Storage Temperature and Quality of Leucoreduced Whole Blood
BFF
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BFF
Sponsor study identifier
interventional
87
1 country
1
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2016
Actual (reported)Study Completion
July 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 1, 2013
Actual (reported)July 4, 2013
Actual (reported)July 2016
Actual (reported)July 2016
Actual (reported)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
Leukocyte count
After leukocyte filtration
Hemolysis
After 42 days of storage
Leukocyte-reduced whole blood, 2 hours holding-time after collection. Gravitational filtration. Device: Terumo IMUFLEX WB(Whole blood)-SP(saving platelets) collection bag system
Non-leukocyte-reduced whole blood, 2 hours holding-time after collection. Device: Terumo IMUFLEX WB-SP collection bag system
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Haukeland University Hospital, Dept of Immunology and Transfusion Medicine
Bergen, 5021, Norway
Geir Strandenes, MD
Haukeland University Hospital and Norwegian Naval Special Operation Commando
87 participants (actual enrollment reported by the registry).
First Submitted
July 1, 2013
First Posted
July 4, 2013
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
FAST Learning Methods
Leukocyte-reduced whole blood, no holding-time after collection. Gravitational filtration. Device: Terumo IMUFLEX WB-SP collection bag system
Leukocyte-reduced whole blood, no holding-time after collection. Forced filtration. Device: Terumo IMUFLEX WB-SP collection bag system
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.
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.
Contact the study team to confirm eligibility.
Primary Completion
July 2016
Actual (reported)Study Completion
July 2016
Actual (reported)Last Updated
March 19, 2024
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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