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Completed

NCT Number: NCT05623670

Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation

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.

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Key information

Conditions

Post-interventional VJI Thrombi After CPB

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation for Minimally Invasive Cardiac Surgery.

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Nov 21, 2022
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.