Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation

• Sponsor: Goethe University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05623670
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-interventional VJI Thrombi After CPB	Procedure: minimally invasive cardiac surgery using a VJI cannula.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 45 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation for Minimally Invasive Cardiac Surgery.
• Actual Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Incidence of post-interventional internal jugular vein thrombi [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Frankfurt	Frankfurt	Hessen	Germany	60590

Sponsors and Collaborators

• Goethe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Armin N. Flinspach, intensivist, Goethe University
• ClinicalTrials.gov Identifier: NCT05623670
• Other Study ID Numbers: VJI thrombi after CPB cervical
• First Posted: Nov 21, 2022
• Last Update Posted: Dec 28, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thrombosis

Study Results

No Results Posted as of Dec 28, 2022