Isolated Heart Valve SurgeryNCT05151796
Continuation of Aspirin Before Isolated Heart Valve Surgery
An observational study of Isolated Heart Valve Surgery, run by University of Liege at 1 site in Belgium.
Trial summary
Whether or not continuing aspirin up to de day before surgery increases the risk of bleeding and/or prevents thrombo-embolic complications remains debated. The investigators retrospectively investigated the whether continuing aspirine within 5 days of isolated heart valve surgery increased the risk of bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Isolated Heart Valve Surgery
- What is being tested?
- Aspirin
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2012to 1 Dec 2021
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients undergoing isolated heart valve surgery at the University Hospital of Liege (Belgium)
Who may be able to join
- Isolated heart valve surgery
Who cannot join
- Antiplatelet agent other than aspirin or anticoagulant not discontinued preoperatively
- Emergent or salvage surgery
- Surgery for endocarditis
- Use of NSAIDs within 48 hours before surgery
Trial locations and contacts
1 site in 1 country.
Gregory Hans, MD contact
Belgium1 site, 1 recruiting
- Recruiting
CHU of Liege
Liège, Liege, 4000
Gregory Hans, MD, PhD, G.Hans@chuliege.be
Alan Houben, MD, ahouben@student.uliege.be
About this study
Official title: Effect of Continuation of Aspirin Before Isolated Heart Valve Surgery on Postoperative Bleeding and Transfusion: a Single-center Retrospective Study
Whether or not continuing aspirin up to de day before surgery increases the risk of bleeding and/or prevents thrombo-embolic complications remains debated. The investigators retrospectively investigated the whether continuing aspirine within 5 days of isolated heart valve surgery increased the risk of bleeding.
- Conditions
- Isolated Heart Valve Surgery
- Being tested
- Aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Daily aspirin intake for cardiovascular prevention
| Study group | Role | What they receive |
|---|---|---|
| Aspirin continued within 5 days before surgery | Not described Receives: Drug: Aspirin | |
| Aspirin discontinued more than 5 days before surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of units of packed red blood cells transfused anytime during the hospital stay
Measured: 30 days
Secondary outcomes (4)
Chest tube drainage
volume of chest tube drainage
Measured: 24 hours
Surgical revision for bleeding
Measured: 24 hours
Any thrombo-embolic complication
Measured: 30 days
Transfusion of any type of blood product
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 posted9 Dec 2021
- Study start1 May 2012
- Primary completion1 May 2017
- Study completion1 Dec 2021 (estimated)
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 Isolated Heart Valve SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
- Investigators
- Vincent Bonhomme, MD, PhD, Study chair, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151796
- Sponsor's protocol ID
- ulganescardio_aspirine
- Status last verified
- Nov 2021
- First submitted
- 5 Oct 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Houben AM, Crepy M, Senard M, Bonhomme V, Tchana-Sato V, Hans G. Preoperative continuation of aspirin before isolated heart valve surgery and postoperative bleeding and transfusion: a single-center retrospective study. Acta Chir Belg. 2024 Aug;124(4):274-280. doi: 10.1080/00015458.2023.2298097. Epub 2023 Dec 26.
PubMed 38146908
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuation of Aspirin Before Isolated Heart Valve Surgery on Postoperative Bleeding and Transfusion: a Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT05151796
- Acronym / sponsor ID
- ulganescardio_aspirine
- Conditions
- Isolated Heart Valve Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 9 Dec 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.
Whether or not continuing aspirin up to de day before surgery increases the risk of bleeding and/or prevents thrombo-embolic complications remains debated. The investigators retrospectively investigated the whether continuing aspirine within 5 days of isolated heart valve surgery increased the risk of bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin continued within 5 days before surgery | – | Drug: Aspirin |
| Aspirin discontinued more than 5 days before surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing isolated heart valve surgery at the University Hospital of Liege (Belgium)
Key inclusion criteria (1 listed)
- Isolated heart valve surgery
Key exclusion criteria (4 listed)
- Antiplatelet agent other than aspirin or anticoagulant not discontinued preoperatively
- Emergent or salvage surgery
- Surgery for endocarditis
- Use of NSAIDs within 48 hours before surgery
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 |
|---|---|---|
| AspirinDaily aspirin intake for cardiovascular prevention | Drug | Aspirin continued within 5 days before surgery |
Primary outcome
The number of units of packed red blood cells transfused anytime during the hospital stay
Time frame: 30 days
4 secondary outcomes
Chest tube drainage
Time frame: 24 hours
Surgical revision for bleeding
Time frame: 24 hours
Any thrombo-embolic complication
Time frame: 30 days
Transfusion of any type of blood product
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Derived from this study: PubMed 38146908Houben AM, Crepy M, Senard M, Bonhomme V, Tchana-Sato V, Hans G. Preoperative continuation of aspirin before isolated heart valve surgery and postoperative bleeding and transfusion: a single-center retrospective study. Acta Chir Belg. 2024 Aug;124(4):274-280. doi: 10.1080/00015458.2023.2298097. Epub 2023 Dec 26.
- 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.
Gregory Hans, MD contact
Vincent Bonhomme, MD, PhD study chair
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isolated Heart Valve Surgery, run by University of Liege at 1 site in Belgium.
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 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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. 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 Belgium. 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 Gregory Hans, MD (G.Hans@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of units of packed red blood cells transfused anytime during the hospital stay (time frame: 30 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 NCT05151796, 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 9 Dec 2021.