Overview

This trial is active, not recruiting.

Conditions trauma, austere environment, blood bank, buddy transfusion
Treatment donation of 1 whole blood unit
Sponsor Haukeland University Hospital
Collaborator Norwegian Armed Forces Medical Service
Start date March 2013
End date July 2016
Trial size 80 participants
Trial identifier NCT01892670, 2012/2279

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(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
donation of 1 whole blood unit Terumo IMUFLEX WB-SP collection bag system.
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
(Experimental)
Non-leukocyte-reduced whole blood, 2 hours holding-time after collection. Device: Terumo IMUFLEX WB-SP collection bag system
donation of 1 whole blood unit Terumo IMUFLEX WB-SP collection bag system.
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
(Experimental)
Leukocyte-reduced whole blood, no holding-time after collection. Gravitational filtration. Device: Terumo IMUFLEX WB-SP collection bag system
donation of 1 whole blood unit Terumo IMUFLEX WB-SP collection bag system.
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
(Experimental)
Leukocyte-reduced whole blood, no holding-time after collection. Forced filtration. Device: Terumo IMUFLEX WB-SP collection bag system
donation of 1 whole blood unit Terumo IMUFLEX WB-SP collection bag system.
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
(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.
donation of 1 whole blood unit Terumo IMUFLEX WB-SP collection bag system.
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
(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.
donation of 1 whole blood unit Terumo IMUFLEX WB-SP collection bag system.
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.

Primary Outcomes

Measure
Platelet function
time frame: After 10 days of cold-storage

Secondary Outcomes

Measure
Leukocyte count
time frame: After leukocyte filtration

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Storage Temperature and Quality of Leucoreduced Whole Blood
Principal investigator Geir Strandenes, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Haukeland University Hospital.