Blood Loss, SurgicalNCT04574128
Retransfusion or Not of Cardiotomy Blood
A study testing No retransfusion of cardiotomy blood in people with Blood Loss, Surgical, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
This randomised controlled trial has a non-inferiority design. The aim is to test if the blood loss (volume in mL and hemoglobin) is effected by heart and lung cardiotomy retransfusion, or not? Forty CABG (Coronary Artery By pass Grafting) patients will be allocated to either receive retransfusion (n=20) of cardiotomy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- No retransfusion of cardiotomy blood
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2020to 30 Dec 2022
- 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
- Elective CABG.
Who cannot join
- Anaemia, infection, massive bleeding, CABG off pump.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University Hospital in Örebro
Örebro, 70185
Camilla Wistrand, PhD, +46707686938, camilla.wistrand@regionorebrolan.se
About this study
Official title: Blood Loss With Cardiopulmonary Bypass, Re-transfusion or Not.
This randomised controlled trial has a non-inferiority design. The aim is to test if the blood loss (volume in mL and hemoglobin) is effected by heart and lung cardiotomy retransfusion, or not? Forty CABG (Coronary Artery By pass Grafting) patients will be allocated to either receive retransfusion (n=20) of cardiotomy blood via the heart and lung mashine, or no retransfusion (n=20).
- Conditions
- Blood Loss, Surgical
- Being tested
- No retransfusion of cardiotomy blood
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No retransfusion of cardiotomy bloodProcedure or surgery
No retransfusion of cardiotomy blood via heart- and lung mashine
| Study group | Role | What they receive |
|---|---|---|
| Retransfusion of cardiotomy blood or not | Experimental | Intervention group does not get cardiotomy blood retransfusion via heart-and lung machine while control does. Receives: Procedure: No retransfusion of cardiotomy blood |
| No retransfusion of cardiotomy blood | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
Hemoglobin
Measured: During 5 days hemoglobin will be measured as the clinical rutine or as needed.
Blood loss
Blood volume in millilitre (mL)
Measured: During 2 days or while surgical drains remains, blood volume in mL is measured.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- Randomised controlled non-inferiority trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camilla Wistrand, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574128
- Sponsor's protocol ID
- ECC 2020
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analysed during the current study are not publicly available due to ethical considerations of the participant integrity. Bacterial growth can be seen as sensitive data. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Loss With Cardiopulmonary Bypass, Re-transfusion or Not.
- ClinicalTrials.gov ID
- NCT04574128
- Acronym / sponsor ID
- ECC 2020
- Conditions
- Blood Loss, Surgical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 5 Oct 2020 (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.
This randomised controlled trial has a non-inferiority design. The aim is to test if the blood loss (volume in mL and hemoglobin) is effected by heart and lung cardiotomy retransfusion, or not? Forty CABG (Coronary Artery By pass Grafting) patients will be allocated to either receive retransfusion (n=20) of cardiotomy blood via the heart and lung mashine, or no retransfusion (n=20).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomised controlled non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Retransfusion of cardiotomy blood or not | Experimental | Procedure: No retransfusion of cardiotomy bloodIntervention group does not get cardiotomy blood retransfusion via heart-and lung machine while control does. |
| No retransfusion of cardiotomy blood | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective CABG.
Key exclusion criteria (1 listed)
- Anaemia, infection, massive bleeding, CABG off pump.
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 |
|---|---|---|
| No retransfusion of cardiotomy bloodNo retransfusion of cardiotomy blood via heart- and lung mashine | Procedure or surgery | Retransfusion of cardiotomy blood or not |
Primary outcome
blood loss
Time frame: During 5 days hemoglobin will be measured as the clinical rutine or as needed.
Hemoglobin
Blood loss
Time frame: During 2 days or while surgical drains remains, blood volume in mL is measured.
Blood volume in millilitre (mL)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No. The datasets generated and/or analysed during the current study are not publicly available due to ethical considerations of the participant integrity. Bacterial growth can be seen as sensitive data. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
Camilla Wistrand, PhD principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No retransfusion of cardiotomy blood in people with Blood Loss, Surgical, run by Örebro University, Sweden at 1 site in Sweden.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Oct 2020. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camilla Wistrand, PhD (+460707686938, camilla.wistrand@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss (time frame: During 5 days hemoglobin will be measured as the clinical rutine or as needed.). 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 5 Oct 2020.