BleedingNCT04988620
Cold Stored Whole Blood in Cardiothoracic Surgery
A study testing Whole Blood transfusion in people with Bleeding, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
In vitro platelet function and post-transfusion platelet recovery of platelets stored in whole blood decline during storage. In this pilot randomized clinical trial we aim to investigate the impact of storage time of whole blood on the effect and safety in treatment of immediate blood loss in patients undergoing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding
- What is being tested?
- Whole Blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- 4 Jun 2021to 11 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing cardiothoracic, cardiac, or aortic surgery
- Patients with complex surgical procedures and expected cardiopulmonary bypass (CPB) time over 120 minutes
- Patients capable of providing informed consent to participate in the study
Who cannot join
- Patients not capable of providing informed consent to participate or who will not provide informed consent
- Patients with known congenital coagulopathies or hemostatic disorders (von Willebrands Disease, hemophilia etc)
- Patients with known erythrocyte- or platelet/HLA antibodies
- Patients with a particular increased surgical risk with expected need of ECMO
- Patients with preoperative EuroScore II ≥ 30
- 5. RhD negative patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cold Stored Whole Blood in Treatment of Bleeding in Patients Undergoing Cardiothoracic Surgery
In vitro platelet function and post-transfusion platelet recovery of platelets stored in whole blood decline during storage. In this pilot randomized clinical trial we aim to investigate the impact of storage time of whole blood on the effect and safety in treatment of immediate blood loss in patients undergoing complex cardiothoracic surgery. The study is designed as an exploratory superiority study to support feasibility and provide critical guidance for future, more definitive randomized trials. In the study the test group will receive CPD whole blood leukocyte-depleted with a platelet-sparing filter and stored for 15-21 days whereas the control group patients will receive leukocyte-depleted CPD whole blood stored for less than 7 days.
Read the detailed description
A challenge for implementation of Whole Blood programs in civilian health services has been an uncertainty regarding the impact of storage on the clinical effect of the whole blood transfusion, especially when it comes to platelet function which is essential to hemostasis. In vitro platelet function and post-transfusion platelet recovery decline with increasing storage time of the whole blood.
In this pilot randomized clinical trial we aim to investigate the impact of storage time of whole blood on the effect and safety in treatment of immediate blood loss in patients undergoing complex cardiothoracic surgery. The study is designed as an exploratory superiority study to support feasibility and provide critical guidance for future, more definitive randomized trials. In the study the test group will receive CPD whole blood leukocyte-depleted with a platelet-sparing filter and stored for 15-21 days whereas the control group patients will receive leukocyte-depleted CPD whole blood stored for less than 7 days. A control group receiving standard care (blood component-based transfusion) may be included.
- Conditions
- Bleeding
- Being tested
- Whole Blood transfusion
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Blood transfusionOther
In this study the effect of storage time of whole blood will be investigated. Intervention is storage of whole blood.
| Study group | Role | What they receive |
|---|---|---|
| Whole Blood stored for 15-21 days | Experimental | CPD Whole Blood leukoreduced with a platelet-sparing filter and stored cold for 15-21 days Receives: Other: Whole Blood transfusion |
| Whole Blood stored for less than 7 days | Active comparator | CPD Whole Blood leukoreduced with a platelet-sparing filter and stored cold for less than 7 days. We aim at using as fresh as possible. Receives: Other: Whole Blood transfusion |
| Whole Blood stored for 8-14 days | Active comparator | CPD Whole Blood leukoreduced with a platelet-sparing filter and stored cold for 8-14 days. This group may be added if deemed of interest after interim analysis. Receives: Other: Whole Blood transfusion |
| Standard Blood Component | Active comparator | This group may be added for comparison if deemed of interest after interim analysis. Receives: Other: Whole Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Comparison of postoperative immediate blood loss (measured by chest drain output and/or bleeding score) in patients receiving fresher or older cold stored whole blood.
Measured: 24 hours (8:00 am morning after surgery)
Blood usage
Comparison of amount of whole blood and blood components given
Measured: 24 hours (8:00 am morning after surgery)
Secondary outcomes (22)
INR
Coagulation measured as INR
Measured: 24 hours (8:00 am morning after surgery)
APTT
Coagulation measured as APTT
Measured: 24 hours (8:00 am morning after surgery)
Thromboelastography
Thromboelastography (TEG6s)
Measured: 24 hours (8:00 am morning after surgery)
Platelet aggregometry
Platelet aggregation measured by Multiplate impedance aggregometry (Mulitplate analyzer)
Measured: 24 hours (8:00 am morning after surgery)
Platelet count
Platelet count
Measured: 24 hours (8:00 am morning after surgery)
Hemoglobin concentration
Hemoglobin concentration
Measured: 24 hours (8:00 am morning after surgery)
Erythrocyte count
Erythrocyte count
Measured: 24 hours (8:00 am morning after surgery)
Hematocrit
Hematocrit or erytrocyte volume fraction, i.e.the volume percentage (vol%) of red blood cells (RBC) in blood,
Measured: 24 hours (8:00 am morning after surgery)
Fibrinogen concentration
Fibrinogen concentration
Measured: 24 hours (8:00 am morning after surgery)
Metabolomic profile
Investigation of blood cell metabolism and metabolic profile by use of high resolution mass spectometry
Measured: 24 hours (8:00 am morning after surgery)
White blood cell count
White blood cell count
Measured: 24 hours (8:00 am morning after surgery)
Bilirubin
Hemolysis measured as Bilirubin
Measured: Up to 7 days
Haptoglobin
Hemolysis measured as Haptoglobin
Measured: Up to 7 days
Lactate dehydrogenase
Lactate dehydrogenase (LD)
Measured: Up to 7 days
Direct antiglobin test
Direct antiglobin test (DAT)
Measured: Up to 7 days
Anti-A antibodies
Anti-A antibodies
Measured: Up to 7 days
Anti-B antibodies
Anti-B antibodies
Measured: Up to 7 days
Hemostatic agents
Use of hemostatic agents (coagulation factor concentrates, fibriongen concentrate)
Measured: 24 hours (8:00 am morning after surgery)
Other medications
Use of other medications potentially affecting bleeding (including tranexamacid, calcium etc.)
Measured: 24 hours (8:00 am morning after surgery)
Adverse events
Adverse events
Measured: 30 days
Length of stay
Length of stay
Measured: 30 days
Mortality
Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start4 Jun 2021
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Why it stopped: Withdrawn because of recruitment and protocol issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Test group ( Whole Blood stored for 15-21 days) versus Control group(s) (Whole Blood stored for less than 7 days, Whole Blood stored for 8-14 days and/or Standard Blood Component treatment)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Einar K Kristoffersen, PhD, Study chair, Helse Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988620
- Sponsor's protocol ID
- 2019/01294
- Other IDs
- 2019
- Status last verified
- Jul 2025
- First submitted
- 4 Jun 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Stored Whole Blood in Treatment of Bleeding in Patients Undergoing Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT04988620
- Acronym / sponsor ID
- 2019/01294
- Conditions
- Bleeding
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn because of recruitment and protocol issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 3 Aug 2021 (actual)
- 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 vitro platelet function and post-transfusion platelet recovery of platelets stored in whole blood decline during storage. In this pilot randomized clinical trial we aim to investigate the impact of storage time of whole blood on the effect and safety in treatment of immediate blood loss in patients undergoing complex cardiothoracic surgery. The study is designed as an exploratory superiority study to support feasibility and provide critical guidance for future, more definitive randomized trials. In the study the test group will receive CPD whole blood leukocyte-depleted with a platelet-sparing filter and stored for 15-21 days whereas the control group patients will receive leukocyte-depleted CPD whole blood stored for less than 7 days.
Detailed description
A challenge for implementation of Whole Blood programs in civilian health services has been an uncertainty regarding the impact of storage on the clinical effect of the whole blood transfusion, especially when it comes to platelet function which is essential to hemostasis. In vitro platelet function and post-transfusion platelet recovery decline with increasing storage time of the whole blood.
In this pilot randomized clinical trial we aim to investigate the impact of storage time of whole blood on the effect and safety in treatment of immediate blood loss in patients undergoing complex cardiothoracic surgery. The study is designed as an exploratory superiority study to support feasibility and provide critical guidance for future, more definitive randomized trials. In the study the test group will receive CPD whole blood leukocyte-depleted with a platelet-sparing filter and stored for 15-21 days whereas the control group patients will receive leukocyte-depleted CPD whole blood stored for less than 7 days. A control group receiving standard care (blood component-based transfusion) may be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Test group ( Whole Blood stored for 15-21 days) versus Control group(s) (Whole Blood stored for less than 7 days, Whole Blood stored for 8-14 days and/or Standard Blood Component treatment)
| Arm | Type | Receives |
|---|---|---|
| Whole Blood stored for 15-21 days | Experimental | Other: Whole Blood transfusionCPD Whole Blood leukoreduced with a platelet-sparing filter and stored cold for 15-21 days |
| Whole Blood stored for less than 7 days | Active comparator | Other: Whole Blood transfusionCPD Whole Blood leukoreduced with a platelet-sparing filter and stored cold for less than 7 days. We aim at using as fresh as possible. |
| Whole Blood stored for 8-14 days | Active comparator | Other: Whole Blood transfusionCPD Whole Blood leukoreduced with a platelet-sparing filter and stored cold for 8-14 days. This group may be added if deemed of interest after interim analysis. |
| Standard Blood Component | Active comparator | Other: Whole Blood transfusionThis group may be added for comparison if deemed of interest after interim analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing cardiothoracic, cardiac, or aortic surgery
- Patients with complex surgical procedures and expected cardiopulmonary bypass (CPB) time over 120 minutes
- Patients capable of providing informed consent to participate in the study
Key exclusion criteria (6 listed)
- Patients not capable of providing informed consent to participate or who will not provide informed consent
- Patients with known congenital coagulopathies or hemostatic disorders (von Willebrands Disease, hemophilia etc)
- Patients with known erythrocyte- or platelet/HLA antibodies
- Patients with a particular increased surgical risk with expected need of ECMO
- Patients with preoperative EuroScore II ≥ 30
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 |
|---|---|---|
| Whole Blood transfusionIn this study the effect of storage time of whole blood will be investigated. Intervention is storage of whole blood. | Other | Standard Blood Component, Whole Blood stored for 15-21 days, Whole Blood stored for 8-14 days, Whole Blood stored for less than 7 days |
Primary outcome
Blood loss
Time frame: 24 hours (8:00 am morning after surgery)
Comparison of postoperative immediate blood loss (measured by chest drain output and/or bleeding score) in patients receiving fresher or older cold stored whole blood.
Blood usage
Time frame: 24 hours (8:00 am morning after surgery)
Comparison of amount of whole blood and blood components given
22 secondary outcomes
INR
Time frame: 24 hours (8:00 am morning after surgery)
APTT
Time frame: 24 hours (8:00 am morning after surgery)
Thromboelastography
Time frame: 24 hours (8:00 am morning after surgery)
Platelet aggregometry
Time frame: 24 hours (8:00 am morning after surgery)
Platelet count
Time frame: 24 hours (8:00 am morning after surgery)
Hemoglobin concentration
Time frame: 24 hours (8:00 am morning after surgery)
Erythrocyte count
Time frame: 24 hours (8:00 am morning after surgery)
Hematocrit
Time frame: 24 hours (8:00 am morning after surgery)
Fibrinogen concentration
Time frame: 24 hours (8:00 am morning after surgery)
Metabolomic profile
Time frame: 24 hours (8:00 am morning after surgery)
White blood cell count
Time frame: 24 hours (8:00 am morning after surgery)
Bilirubin
Time frame: Up to 7 days
Haptoglobin
Time frame: Up to 7 days
Lactate dehydrogenase
Time frame: Up to 7 days
Direct antiglobin test
Time frame: Up to 7 days
Anti-A antibodies
Time frame: Up to 7 days
Anti-B antibodies
Time frame: Up to 7 days
Hemostatic agents
Time frame: 24 hours (8:00 am morning after surgery)
Other medications
Time frame: 24 hours (8:00 am morning after surgery)
Adverse events
Time frame: 30 days
Length of stay
Time frame: 30 days
Mortality
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- 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.
Einar K Kristoffersen, PhD study chair
Helse Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Blood transfusion in people with Bleeding, 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 21 Oct 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Blood loss (time frame: 24 hours (8:00 am morning after surgery)). The study lists 2 primary outcomes in all. 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 21 Oct 2026.