Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation

NCT05623670 | Completed

• 1 other identifier: VJI thrombi after CPB cervical
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Post-interventional VJI Thrombi After CPB

Outcome Measures

Primary Outcomes (1)

• 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.

  Detection of thrombi within 24 hours post-intervention

Study Arms (1)

Patients after minimally invasive cardiac surgery using a VJI cannula.

Procedure: minimally invasive cardiac surgery using a VJI cannula.

Interventions

minimally invasive cardiac surgery using a VJI cannula. PROCEDURE

Observation of postinterventional internal jugular vein thrombus after minimally invasive cardiac surgery using VJI cannulation to achieve complete CPB.

Patients after minimally invasive cardiac surgery using a VJI cannula.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients undergoing minimally invasive cardiac surgery requiring full cardiopulmonary bypass at our centre during the observation period.

You may qualify if:

• \- Minimally invasive cardiac surgery carried out using complete cardiopulmonary bypass.

You may not qualify if:

• 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

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: intensivist

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: November 21, 2022
• Study Start: December 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)