Storage Temperature and Quality of Leucoreduced Whole Blood

NCT ID: NCT01892670

Last Updated: 2024-03-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Trauma Austere Environment Blood Bank Buddy Transfusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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

Group Type EXPERIMENTAL

Donation of 1 whole blood unit

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Donation of 1 whole blood unit

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Donation of 1 whole blood unit

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Donation of 1 whole blood unit

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Donation of 1 whole blood unit

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Donation of 1 whole blood unit

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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Terumo IMUFLEX WB-SP collection bag system.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Norwegian Armed Forces Medical Service

OTHER_GOV

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Norway

Related Links

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http://rdcr.org/

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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