TraumaBFFNCT01892670
Storage Temperature and Quality of Leucoreduced Whole Blood
A study testing Donation of 1 whole blood unit in people with Trauma and Austere Environment, run by Haukeland University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Austere Environment, Blood Bank
- What is being tested?
- Donation of 1 whole blood unit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Usage of platelet-influencing medication
- Mild flu or more severe illnesses
- Open wound
- Pregnancy or trying to get pregnant
Trial locations and contacts
1 site in 1 country.
Norway1 site
Haukeland University Hospital, Dept of Immunology and Transfusion Medicine
Bergen, 5021
About this study
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.
- Conditions
- Trauma, Austere Environment, Blood Bank, Buddy Transfusion
- Being tested
- Donation of 1 whole blood unit
- Keywords
- Blood, Whole blood, Cold-storage, Filtration, Transfusion, Platelet-function
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donation of 1 whole blood unitOther
Also called Terumo IMUFLEX WB-SP collection bag system.
Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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. Receives: 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. Receives: Other: Donation of 1 whole blood unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet function
Platelet function is assessed by various parameters, such as thrombelastography (TEG), Multiplate and flow cytometry (Lactadherin, Calcein violet AM, ++).
Measured: After 10 days of cold-storage
Secondary outcomes (1)
Leukocyte count
Filtered whole blood should have a concentration less than 1*10^6 cells/L to avoid transfusion reactions.
Measured: After leukocyte filtration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Armed Forces Medical Service
- Responsible party
- Sponsor
- Investigators
- Geir Strandenes, MD, Principal investigator, Haukeland University Hospital and Norwegian Naval Special Operation Commando
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892670
- Sponsor's protocol ID
- 2012/2279
- Acronym
- BFF
- Status last verified
- Aug 2017
- First submitted
- 1 Jul 2013
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Storage Temperature and Quality of Leucoreduced Whole Blood
- ClinicalTrials.gov ID
- NCT01892670
- Acronym / sponsor ID
- BFF / 2012/2279
- Conditions
- Trauma, Austere Environment, Blood Bank, Buddy Transfusion
- Keywords
- Blood, Whole blood, Cold-storage, Filtration, Transfusion, Platelet-function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Armed Forces Medical Service
- Study start
- Mar 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Filtered whole blood | Experimental | Other: Donation of 1 whole blood unitLeukocyte-reduced whole blood, 2 hours holding-time after collection. Gravitational filtration. Device: Terumo IMUFLEX WB(Whole blood)-SP(saving platelets) collection bag system |
| Unfiltered whole blood | Experimental | Other: Donation of 1 whole blood unitNon-leukocyte-reduced whole blood, 2 hours holding-time after collection. Device: Terumo IMUFLEX WB-SP collection bag system |
| Warm-filtered whole blood | Experimental | Other: Donation of 1 whole blood unitLeukocyte-reduced whole blood, no holding-time after collection. Gravitational filtration. Device: Terumo IMUFLEX WB-SP collection bag system |
| Forced warm-filtration of whole bood | Experimental | Other: Donation of 1 whole blood unitLeukocyte-reduced whole blood, no holding-time after collection. Forced filtration. Device: Terumo IMUFLEX WB-SP collection bag system |
| RCC produced from cold-stored whole blood | Experimental | Other: Donation of 1 whole blood unitRCC 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. |
| RCC produced from cold-stored non-filtered whole blood | Experimental | Other: Donation of 1 whole blood unitRCC 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Usage of platelet-influencing medication
- Mild flu or more severe illnesses
- Open wound
- Pregnancy or trying to get pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donation of 1 whole blood unitAlso: Terumo IMUFLEX WB-SP collection bag system.Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines. | Other | Filtered whole blood, Forced warm-filtration of whole bood, RCC produced from cold-stored non-filtered whole blood, RCC produced from cold-stored whole blood, Unfiltered whole blood, Warm-filtered whole blood |
Primary outcome
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, ++).
1 secondary outcome
Leukocyte count
Time frame: After leukocyte filtration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- 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 centerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geir Strandenes, MD principal investigator
Haukeland University Hospital and Norwegian Naval Special Operation Commando
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donation of 1 whole blood unit in people with Trauma and Austere Environment, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet function (time frame: After 10 days of cold-storage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.