CONTINUOUS POSTOPERATIVE PERICARDIAL FLUSHING AFTER GENERAL CARDIAC SURGERY PROCEDURES WITH THE HAERMONICS INVESTIGATIONAL DEVICE : STUDY PROTOCOL OF THE FLUID (FLUsh with Investigational Device) TRIA

Completed

• Conditions: postoperative hemorage; 10034468; 10062915; 10007593

• Registration Number: NL-OMON54160
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 992

Inclusion Criteria

Adults undergoing a general cardiothoracic surgery procedure with the use of
cardiopulmonary bypass are eligible for participation

Exclusion Criteria

Euroscore II > 20% , Intraoperatively diaphragm injury leading to an open
connection between the thoracic and abdominal cavity, Age < 18, Inability to
understand study information, Participation in any study involving an
investigational drug or device, Emergent procedures, Procedures performed off
pump, without the use of cardiopulmonary bypass, Minimal invasive cardiac
surgery procedures (e.g. minithoracotomy and hemisternotomy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the incidence of re-exploration for cardiac<br /><br>tamponade and/or excessive bleeding due to non-surgical bleeding</p><br>