NCT05598385

Brief 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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2024

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
2 years until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2024

Completed
Last Updated

November 29, 2024

Status Verified

March 1, 2024

Enrollment Period

8 days

First QC Date

October 26, 2022

Last Update Submit

November 26, 2024

Conditions

Cardiovascular Diseases

Keywords

Peripheral cannulationOpen cannulationPercutaneous cannulationMinimally invasive cardiac surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    Until 30 days postoperatively

Study Arms (2)

Percutaneous cannulation

ACTIVE COMPARATOR

Percutaneous peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation.

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.

Procedure: Open cannulation

Interventions

Open cannulationPROCEDURE

A small incision is made to access the FA and FA. Afterwards, the incision site is traditionally closed with sutures.

Open cannulation
Percutaneous cannulationPROCEDURE

Cannulation is performed through a suture-mediated closure system.

Percutaneous cannulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years
  • Patients undergoing elective endoscopic cardiac surgery

You may not qualify if:

  • Patients that do no understand Dutch, French, or English
  • Heavily calcified cannula introduction site
  • Central cannulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Alaaddin Yilmaz, MD

    Jessa Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

October 28, 2022

Study Start

November 1, 2024

Primary Completion

November 9, 2024

Study Completion

November 9, 2024

Last Updated

November 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share