Storage Temperature and Quality of Leucoreduced Whole Blood (BFF)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Norwegian Armed Forces Medical Service
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01892670
First received: July 1, 2013
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

In a combat situation the need for safe and high-quality blood products is increasing. 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.

Analyses are performed with a main focus to investigate function and quality of red blood cells and platelets.


Condition Intervention
Whole Blood
Platelet Function
Hemolysis
Filtration
Other: Donation of 1 whole blood unit

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Storage Temperature and Quality of Leucoreduced Whole Blood

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Platelet function [ Time Frame: After 10 days of cold-storage ] [ Designated as safety issue: No ]
    Platelet function is assessed by various parameters, such as thrombelastography (TEG), Multiplate and flow cytometry (Lactadherin, Calcein violet AM, ++).


Secondary Outcome Measures:
  • Leukocyte count [ Time Frame: After leukocyte filtration ] [ Designated as safety issue: Yes ]
    Filtered whole blood should have a concentration less than 1*10^6 cells/L to avoid transfusion reactions.


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Filtered whole blood

Leukocyte-reduced whole blood, 2 hours 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.
  • (IMUFLEX® WB-SP features an in-line, saving-platelets filter that provides a way to
  • produce a leukocyte-reduced platelet concentrate — from whole blood.)
Active Comparator: 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.
  • (IMUFLEX® WB-SP features an in-line, saving-platelets filter that provides a way to
  • produce a leukocyte-reduced platelet concentrate — from whole blood.)
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.
  • (IMUFLEX® WB-SP features an in-line, saving-platelets filter that provides a way to
  • produce a leukocyte-reduced platelet concentrate — from whole blood.)
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.
  • (IMUFLEX® WB-SP features an in-line, saving-platelets filter that provides a way to
  • produce a leukocyte-reduced platelet concentrate — from whole blood.)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892670

Locations
Norway
Haukeland University Hospital, Dept of Immunology and Transfusion Medicine
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Norwegian Armed Forces Medical Service
Investigators
Principal Investigator: Geir Strandenes, MD Haukeland University Hospital and Norwegian Naval Special Operation Commando
  More Information

Additional Information:
No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01892670     History of Changes
Other Study ID Numbers: 2012/2279
Study First Received: July 1, 2013
Last Updated: July 12, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
Blood
Whole blood
Cold-storage
Filtration
Transfusion
Platelet-function

Additional relevant MeSH terms:
Hemolysis
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014