Storage Temperature and Quality of Leucoreduced Whole Blood (BFF)

Haukeland University Hospital

Status: Completed

Conditions: Austere Environment; Blood Bank; Trauma; Buddy Transfusion

Treatments: Other: Donation of 1 whole blood unit

Study type: Interventional

Funder types: Other

Identifiers

NCT01892670

2012/2279

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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87 participants in 6 patient groups

Filtered whole blood

Experimental group

Description:

Leukocyte-reduced whole blood, 2 hours holding-time after collection. Gravitational filtration. Device: Terumo IMUFLEX WB(Whole blood)-SP(saving platelets) collection bag system

Treatment:

Other: Donation of 1 whole blood unit

Unfiltered whole blood

Experimental group

Description:

Non-leukocyte-reduced whole blood, 2 hours holding-time after collection. Device: Terumo IMUFLEX WB-SP collection bag system

Treatment:

Other: Donation of 1 whole blood unit

Warm-filtered whole blood

Experimental group

Description:

Leukocyte-reduced whole blood, no holding-time after collection. Gravitational filtration. Device: Terumo IMUFLEX WB-SP collection bag system

Treatment:

Other: Donation of 1 whole blood unit

Forced warm-filtration of whole bood

Experimental group

Description:

Leukocyte-reduced whole blood, no holding-time after collection. Forced filtration. Device: Terumo IMUFLEX WB-SP collection bag system

Treatment:

Other: Donation of 1 whole blood unit

RCC produced from cold-stored whole blood

Experimental group

Description:

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.

Treatment:

Other: Donation of 1 whole blood unit

RCC produced from cold-stored non-filtered whole blood

Experimental group

Description:

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.

Treatment:

Other: Donation of 1 whole blood unit