NCT01892670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 19, 2024

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

July 1, 2013

Last Update Submit

March 18, 2024

Conditions

TraumaAustere EnvironmentBlood BankBuddy Transfusion

Keywords

BloodWhole bloodCold-storageFiltrationTransfusionPlatelet-function

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Leukocyte count

    After leukocyte filtration

Other Outcomes (1)

  • Hemolysis

    After 42 days of storage

Study Arms (6)

Filtered whole blood

EXPERIMENTAL

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

Other: Donation of 1 whole blood unit

Unfiltered whole blood

EXPERIMENTAL

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

Other: Donation of 1 whole blood unit

Warm-filtered whole blood

EXPERIMENTAL

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

Other: Donation of 1 whole blood unit

Forced warm-filtration of whole bood

EXPERIMENTAL

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

Other: Donation of 1 whole blood unit

RCC produced from cold-stored whole blood

EXPERIMENTAL

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.

Other: Donation of 1 whole blood unit

RCC produced from cold-stored non-filtered whole blood

EXPERIMENTAL

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.

Other: Donation of 1 whole blood unit

Interventions

Donation of 1 whole blood unitOTHER

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

Also known as: Terumo IMUFLEX WB-SP collection bag system.
Filtered whole bloodForced warm-filtration of whole boodRCC produced from cold-stored non-filtered whole bloodRCC produced from cold-stored whole bloodUnfiltered whole bloodWarm-filtered whole blood

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Usage of platelet-influencing medication
  • Mild flu or more severe illnesses
  • Open wound
  • Pregnancy or trying to get pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital, Dept of Immunology and Transfusion Medicine

Bergen, 5021, Norway

Location

Related Links

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Geir Strandenes, MD

    Haukeland University Hospital and Norwegian Naval Special Operation Commando

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 4, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 19, 2024

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)