Cardiovascular DiseasesProGlide-IINCT05598385
Groin Complications in Open Vs. Percutaneous Peripheral Cannulation in Minimally Invasive Cardiac Surgery
A study testing Open cannulation and Percutaneous cannulation in people with Cardiovascular Diseases, run by Jessa Hospital.
Trial summary
The aim of this randomized trial is to investigate the groin complications in open vs percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Open cannulation and Percutaneous cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to 9 Nov 2024
- 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
- >18 years
- Patients undergoing elective endoscopic cardiac surgery
Who cannot join
- Patients that do no understand Dutch, French, or English
- Heavily calcified cannula introduction site
- Central cannulation
About this study
Official title: Groin Complications in Open Vs. Percutaneous Peripheral Cannulation for Cardiopulmonary Bypass in Minimally Invasive Cardiac Surgery
The aim of this randomized trial is to investigate the groin complications in open vs percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery
Read the detailed description
The femoral artery (FA) and vein (FV) are considered the preferred site for peripheral cannulation during cardiac surgery. Normally, a small incision is made to access the FA and FV, which is also called open surgical cannulation. Afterwards, the incision site is traditionally closed with sutures (1, 2). However, groin complications such as hematoma, access-site infection and fistulas are complications that can eventually lead to a longer hospital stay (3).
Recently, suture-mediated closure systems (SMCS) have been developed to achieve hemostasis (4). This allows for percutaneous cannulation. Still, little is known about the effects on groin complications after percutaneous cannulation in cardiac surgery. Therefore, a prospective randomized study is now being conducted to investigate the groin complications in open vs. percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery.
- Conditions
- Cardiovascular Diseases
- Being tested
- Open cannulation, Percutaneous cannulation
- Keywords
- Peripheral cannulation, Open cannulation, Percutaneous cannulation, Minimally invasive cardiac surgery
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open cannulationProcedure or surgery
A small incision is made to access the FA and FA. Afterwards, the incision site is traditionally closed with sutures.
Percutaneous cannulationProcedure or surgery
Cannulation is performed through a suture-mediated closure system.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous cannulation | Active comparator | Percutaneous peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation. Receives: Procedure: Percutaneous cannulation |
| Open cannulation | Active comparator | Open peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation. Receives: Procedure: Open cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with groin complications
Groin complications consist of groin-related bleeding, dissection, pseudoaneurysm, seroma, infection of the groin, artery occlusion, and reintervention in the groin. Groin complications are diagnosed by an ultrasound.
Measured: Until 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study startNov 2024 (estimated)
- Primary completion9 Nov 2024
- Study completion9 Nov 2024
Why it stopped: After the passing of the principal investigator, the clinical trial could not be started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alaaddin Yilmaz, MD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598385
- Sponsor's protocol ID
- 2022/148
- Acronym
- ProGlide-II
- Status last verified
- Mar 2024
- First submitted
- 26 Oct 2022
- Last updated
- 29 Nov 2024
- 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 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Groin Complications in Open Vs. Percutaneous Peripheral Cannulation for Cardiopulmonary Bypass in Minimally Invasive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05598385
- Acronym / sponsor ID
- ProGlide-II / 2022/148
- Conditions
- Cardiovascular Diseases
- Keywords
- Peripheral cannulation, Open cannulation, Percutaneous cannulation, Minimally invasive cardiac surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: After the passing of the principal investigator, the clinical trial could not be started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- 9 Nov 2024 (actual)
- Study completion
- 9 Nov 2024 (actual)
- First posted
- 28 Oct 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 aim of this randomized trial is to investigate the groin complications in open vs percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery
Detailed description
The femoral artery (FA) and vein (FV) are considered the preferred site for peripheral cannulation during cardiac surgery. Normally, a small incision is made to access the FA and FV, which is also called open surgical cannulation. Afterwards, the incision site is traditionally closed with sutures (1, 2). However, groin complications such as hematoma, access-site infection and fistulas are complications that can eventually lead to a longer hospital stay (3).
Recently, suture-mediated closure systems (SMCS) have been developed to achieve hemostasis (4). This allows for percutaneous cannulation. Still, little is known about the effects on groin complications after percutaneous cannulation in cardiac surgery. Therefore, a prospective randomized study is now being conducted to investigate the groin complications in open vs. percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous cannulation | Active comparator | Procedure: Percutaneous cannulationPercutaneous peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation. |
| Open cannulation | Active comparator | Procedure: Open cannulationOpen peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years
- Patients undergoing elective endoscopic cardiac surgery
Key exclusion criteria (3 listed)
- Patients that do no understand Dutch, French, or English
- Heavily calcified cannula introduction site
- Central cannulation
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 |
|---|---|---|
| Open cannulationA small incision is made to access the FA and FA. Afterwards, the incision site is traditionally closed with sutures. | Procedure or surgery | Open cannulation |
| Percutaneous cannulationCannulation is performed through a suture-mediated closure system. | Procedure or surgery | Percutaneous cannulation |
Primary outcome
Number of participants with groin complications
Time frame: Until 30 days postoperatively
Groin complications consist of groin-related bleeding, dissection, pseudoaneurysm, seroma, infection of the groin, artery occlusion, and reintervention in the groin. Groin complications are diagnosed by an ultrasound.
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 29 Nov 2024.
- 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.
Alaaddin Yilmaz, MD principal investigator
Jessa Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Open cannulation and Percutaneous cannulation in people with Cardiovascular Diseases, run by Jessa Hospital.
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 2 inclusion and 3 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 29 Nov 2024. 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 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?
Number of participants with groin complications (time frame: Until 30 days postoperatively). 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 29 Nov 2024.