Storage Temperature and Quality of Leucoreduced Whole Blood

Trauma Clinical Trial

— BFF  

Official title:

Storage Temperature and Quality of Leucoreduced Whole Blood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892670
• Other study ID #: 2012/2279
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: July 2016

Study information

• Verified date: August 2017
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Austere Environment
• Blood Bank
• Buddy Transfusion
• Trauma

Intervention

Other:
• Donation of 1 whole blood unit
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital, Dept of Immunology and Transfusion Medicine	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Norwegian Armed Forces Medical Service

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemolysis	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
Primary	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	Leukocyte count	Filtered whole blood should have a concentration less than 1*10^6 cells/L to avoid transfusion reactions.	After leukocyte filtration

External Links

•   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