Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation

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.

Study Overview

• Status: Completed
• Conditions: Post-interventional VJI Thrombi After CPB
• Intervention / Treatment: Procedure: minimally invasive cardiac surgery using a VJI cannula.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • University Hospital Frankfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients after minimally invasive cardiac surgery using a VJI cannula.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Goethe University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: November 12, 2022
• First Submitted That Met QC Criteria: November 12, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: VJI thrombi after CPB cervical

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to national legal restrictions, the publication of individual participant data is not possible without significant obstacles.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No