Storage Temperature and Quality of Leucoreduced Whole Blood

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01892670

Acronym

BFF

Enrollment

Registered

2013-07-04

Start date

2013-03-31

Completion date

2016-07-31

Last updated

2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Austere Environment, Blood Bank, Buddy Transfusion, Trauma

Keywords

Blood, Whole blood, Cold-storage, Filtration, Transfusion, Platelet-function

Brief summary

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.

Interventions

OTHERDonation of 1 whole blood unit

Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
Hemolysis	After 42 days of storage	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)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026