Storage Temperature and Quality of Leucoreduced Whole Blood (BFF)

H

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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