ResternotomyVolu-CABGNCT04533698
Impact of Fluid Resuscitation Protocol on the Incidence of Reoperation for Bleeding After Emergency Cardiopulmonary Bypass Grafting
An observational study of Resternotomy, run by University Hospital, Basel, Switzerland.
Trial summary
This is a retrospective data analysis of patients that underwent elective or emergency cardiopulmonary bypass. Resternotomy due to bleeding is frequent after sternotomy. Also due to implementation of Argipressin into clinical practice fluid resuscitation protocol has changed to more vasopressors and less fluid within… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Resternotomy
- What is being tested?
- Assessment of reason for resternotomy and Assessment of reason for avoidance of resternotomy
- How many people
- 265 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 30 Jun 2024
- Phase
- Observational
- 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 99 years
- All sexes
- Adult, Older adult
Study population: All patients that underwent elective or emergency aortocoronary bypass.
Who may be able to join
- All patients that underwent elective or emergency aortocoronary bypass at the University Hospital Basel between 2009 and 2020.
Who cannot join
- None.
About this study
This is a retrospective data analysis of patients that underwent elective or emergency cardiopulmonary bypass. Resternotomy due to bleeding is frequent after sternotomy. Also due to implementation of Argipressin into clinical practice fluid resuscitation protocol has changed to more vasopressors and less fluid within the past five years. The investigators want to explore the influence of volume resuscitation protocol on incidence of rethoracotomy during the past twenty years.
- Conditions
- Resternotomy
- Being tested
- Assessment of reason for resternotomy, Assessment of reason for avoidance of resternotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of reason for resternotomyOther
No intervention is performed. Reasons for resternotomy (coagulation, fluid balance and other) are retrospectively assessed.
Assessment of reason for avoidance of resternotomyOther
No intervention is performed. Reasons for avoidance resternotomy (coagulation, fluid balance and other) are retrospectively assessed.
| Study group | Role | What they receive |
|---|---|---|
| Resternotomy | Not described Receives: Other: Assessment of reason for resternotomy | |
| No resternotomy | Not described Receives: Other: Assessment of reason for avoidance of resternotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resternotomy
Resternotomy yes or no after elective or emergency aortocoronary bypass
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Jan 2009
- Primary completion31 May 2021
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ResternotomyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexa Hollinger, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533698
- Sponsor's protocol ID
- 2020-01833
- Acronym
- Volu-CABG
- Status last verified
- Apr 2025
- First submitted
- 26 Aug 2020
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bruno J, Varayath M, Gahl B, Miazza J, Gebhard CE, Reuthebuch OT, Eckstein FS, Siegemund M, Hollinger A, Santer D. Conservative fluid resuscitation protocol does not reduce the incidence of reoperation for bleeding after emergency CABG. Sci Rep. 2024 Sep 9;14(1):21037. doi: 10.1038/s41598-024-71028-8.
PubMed 39251616
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fluid Resuscitation Protocol on the Incidence of Reoperation for Bleeding After Emergency Cardiopulmonary Bypass Grafting
- ClinicalTrials.gov ID
- NCT04533698
- Acronym / sponsor ID
- Volu-CABG / 2020-01833
- Conditions
- Resternotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 31 Aug 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 is a retrospective data analysis of patients that underwent elective or emergency cardiopulmonary bypass. Resternotomy due to bleeding is frequent after sternotomy. Also due to implementation of Argipressin into clinical practice fluid resuscitation protocol has changed to more vasopressors and less fluid within the past five years. The investigators want to explore the influence of volume resuscitation protocol on incidence of rethoracotomy during the past twenty years.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resternotomy | – | Other: Assessment of reason for resternotomy |
| No resternotomy | – | Other: Assessment of reason for avoidance of resternotomy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients that underwent elective or emergency aortocoronary bypass.
Key inclusion criteria (1 listed)
- All patients that underwent elective or emergency aortocoronary bypass at the University Hospital Basel between 2009 and 2020.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Assessment of reason for resternotomyNo intervention is performed. Reasons for resternotomy (coagulation, fluid balance and other) are retrospectively assessed. | Other | Resternotomy |
| Assessment of reason for avoidance of resternotomyNo intervention is performed. Reasons for avoidance resternotomy (coagulation, fluid balance and other) are retrospectively assessed. | Other | No resternotomy |
Primary outcome
Resternotomy
Time frame: 7 days
Resternotomy yes or no after elective or emergency aortocoronary bypass
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 4 Apr 2025.
- Derived from this study: PubMed 39251616Bruno J, Varayath M, Gahl B, Miazza J, Gebhard CE, Reuthebuch OT, Eckstein FS, Siegemund M, Hollinger A, Santer D. Conservative fluid resuscitation protocol does not reduce the incidence of reoperation for bleeding after emergency CABG. Sci Rep. 2024 Sep 9;14(1):21037. doi: 10.1038/s41598-024-71028-8.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Resternotomy, run by University Hospital, Basel, Switzerland.
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: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Resternotomy (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04533698, which also lists 1 linked publication.
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 4 Apr 2025.