Post-interventional VJI Thrombi After CPBNCT05623670
Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation
An observational study of Post-interventional VJI Thrombi After CPB, run by Goethe University at 1 site in Germany.
Trial summary
The primary objective of the study is to prospectively analyse the occurrence of post-interventional internal vena jugularis (VJI) thrombi after minimally invasive cardiac surgery using a VJI cannula to perform cardiopulmonary bypass (CPB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-interventional VJI Thrombi After CPB
- What is being tested?
- minimally invasive cardiac surgery using a VJI cannula.
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2022to 1 Apr 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing minimally invasive cardiac surgery requiring full cardiopulmonary bypass at our centre during the observation period.
Who may be able to join
- Minimally invasive cardiac surgery carried out using complete cardiopulmonary bypass.
Who cannot join
- Postoperative support by veno-venous or veno-arterial extracorporeal membrane oxygenation.
- Complications of neck cannula placement or removal.
- Pre-existing occlusion of the vena jugularis interna
- Pre-existing thrombosis of the vena jugularis interna
- Pre-existing prothrombotic coagulation disorder
- Existing catheterisation of the vena jugularis interna within 14 days
- Pre-existing anatomical anomaly of the vena jugularis interna
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation for Minimally Invasive Cardiac Surgery.
The primary objective of the study is to prospectively analyse the occurrence of post-interventional internal vena jugularis (VJI) thrombi after minimally invasive cardiac surgery using a VJI cannula to perform cardiopulmonary bypass (CPB). The study follows the question whether the performance of a jugular cannulation for the operation under CPB regularly causes wall thromboses despite continuous anticoagulation and a short length of stay of a few hours. The thromboses to be assessed for the study will be obtained by bedside (Doppler) sonography by experienced intensive care physicians in the cardiac surgery intensive care unit. A prospective analysis of all minimal invasive procedures performed with regard to thrombi in the VJI.
- Being tested
- minimally invasive cardiac surgery using a VJI cannula.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive cardiac surgery using a VJI cannula.Procedure or surgery
Observation of postinterventional internal jugular vein thrombus after minimally invasive cardiac surgery using VJI cannulation to achieve complete CPB.
| Study group | Role | What they receive |
|---|---|---|
| Patients after minimally invasive cardiac surgery using a VJI cannula. | Not described Receives: Procedure: minimally invasive cardiac surgery using a VJI cannula. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-interventional internal jugular vein thrombi
Incidence of post-interventional internal jugular vein thrombi detectable by bedside (doppler) sonography by experienced intensivists in the cardiosurgical intensive care unit.
Measured: Detection of thrombi within 24 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start1 Dec 2022
- Primary completion1 Feb 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-interventional VJI Thrombi After CPBStudies 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
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin N. Flinspach, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623670
- Sponsor's protocol ID
- VJI thrombi after CPB cervical
- Status last verified
- Jan 2024
- First submitted
- 12 Nov 2022
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to national legal restrictions, the publication of individual participant data is not possible without significant obstacles.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation for Minimally Invasive Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT05623670
- Acronym / sponsor ID
- VJI thrombi after CPB cervical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 21 Nov 2022 (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.
The primary objective of the study is to prospectively analyse the occurrence of post-interventional internal vena jugularis (VJI) thrombi after minimally invasive cardiac surgery using a VJI cannula to perform cardiopulmonary bypass (CPB). The study follows the question whether the performance of a jugular cannulation for the operation under CPB regularly causes wall thromboses despite continuous anticoagulation and a short length of stay of a few hours. The thromboses to be assessed for the study will be obtained by bedside (Doppler) sonography by experienced intensive care physicians in the cardiac surgery intensive care unit. A prospective analysis of all minimal invasive procedures performed with regard to thrombi in the VJI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after minimally invasive cardiac surgery using a VJI cannula. | – | Procedure: minimally invasive cardiac surgery using a VJI cannula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing minimally invasive cardiac surgery requiring full cardiopulmonary bypass at our centre during the observation period.
Key inclusion criteria (1 listed)
- Minimally invasive cardiac surgery carried out using complete cardiopulmonary bypass.
Key exclusion criteria (7 listed)
- Postoperative support by veno-venous or veno-arterial extracorporeal membrane oxygenation.
- Complications of neck cannula placement or removal.
- Pre-existing occlusion of the vena jugularis interna
- Pre-existing thrombosis of the vena jugularis interna
- Pre-existing prothrombotic coagulation disorder
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 |
|---|---|---|
| minimally invasive cardiac surgery using a VJI cannula.Observation of postinterventional internal jugular vein thrombus after minimally invasive cardiac surgery using VJI cannulation to achieve complete CPB. | Procedure or surgery | Patients after minimally invasive cardiac surgery using a VJI cannula. |
Primary outcome
Incidence of post-interventional internal jugular vein thrombi
Time frame: Detection of thrombi within 24 hours post-intervention
Incidence of post-interventional internal jugular vein thrombi detectable by bedside (doppler) sonography by experienced intensivists in the cardiosurgical intensive care unit.
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 7 May 2025.
- Individual participant dataSharing planned: No. Due to national legal restrictions, the publication of individual participant data is not possible without significant obstacles.
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.
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 Post-interventional VJI Thrombi After CPB, run by Goethe University at 1 site in Germany.
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 7 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 7 May 2025. 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 Germany. 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?
Incidence of post-interventional internal jugular vein thrombi (time frame: Detection of thrombi within 24 hours post-intervention). 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 7 May 2025.