Storage Temperature and Quality of Leucoreduced Whole Blood (BFF)

March 18, 2024 updated by: Haukeland University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital, Dept of Immunology and Transfusion Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: Donation of 1 whole blood unit
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
Other Names:
  • Terumo IMUFLEX WB-SP collection bag system.
Experimental: Unfiltered whole blood

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
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
Other Names:
  • Terumo IMUFLEX WB-SP collection bag system.
Experimental: Warm-filtered whole blood

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
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
Other Names:
  • Terumo IMUFLEX WB-SP collection bag system.
Experimental: 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
Other: Donation of 1 whole blood unit
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
Other Names:
  • Terumo IMUFLEX WB-SP collection bag system.
Experimental: 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.
Other: Donation of 1 whole blood unit
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
Other Names:
  • Terumo IMUFLEX WB-SP collection bag system.
Experimental: 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.
Other: Donation of 1 whole blood unit
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
Other Names:
  • Terumo IMUFLEX WB-SP collection bag system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet function
Time Frame: 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, ++).
After 10 days of cold-storage

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemolysis
Time Frame: 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)
After 42 days of storage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Collaborators

Norwegian Armed Forces Medical Service

Investigators

  • Principal Investigator: Geir Strandenes, MD, Haukeland University Hospital and Norwegian Naval Special Operation Commando

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 1, 2013

First Submitted That Met QC Criteria

July 1, 2013

First Posted (Estimated)

July 4, 2013

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012/2279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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