Usability of Pericardial Flushing With the Haermonics Pure System After Cardiac Surgery
NCT Number: NCT06521164
Acronym: USEPURE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgical Blood Loss|Surgical Complication
Interventions: DEVICE: Haermonics Pure system
Sponsor: Haermonics BV
Collaborators: Avania
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2025-05

Summary:
The goal of this clinical trial is to evaluate the usability of the Haermonics Pure system in patients undergoing a cardiac surgery procedure with the use of cardiopulmonary bypass.

All measurements and interventions are standard of care, except pericardial flushing with the Haermonics Pure system.

Primary Outcome Measures: Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire., Used by different user groups in different hospital settings when using the different components of the Haermonics Pure system for the different functionalities. User satisfaction is measured with a user questionaire, containing questions with a scale from 1-4, with 1: very unsatisfied, 2: unsatified; 3 satisfied; 4 very satisfied., For each user at each step for each patient trough study completion, which is expected to be around 3 times a week during approximately 5 months.|Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire., For each user, questions will be asked about the common use of the Hearmonics Pure system using a 0-10 Numeric Rating Scale., for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.|Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire., For each user, questions will be asked about the use of the Hearmonics Pure system in comparison with standard practice, with option 1 Hearmonics Pure system being better, with option 2 no difference, with option 3 standard of care being better., for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.
Secondary Outcome Measures: Safety: Rate of device-related events up to discharge, Descriptive statistics, From enrollment up to discharge or up to 2 weeks after surgery, whichever came first|Safety: Rate of SAEs up to discharge, Relationship with the device will be determined for all SAEs. All events of reoperations, pericardiocetesis and pleurcentesis are considered to be SAEs., From enrollment up to discharge or up to 2 weeks after surgery, whichever came first|Efficacy: Drain fluid output 8 hours after start treatment (with sternum closed)., Total amount of fluid output, comparing this with the historical control established in the previous FLUID trial., start treatment (flushing) up to 8 hours after start treatment (flushing).|Technical Efficacy: Number of device deficiencies leading to permanently stopping the treatment for each patient, 65 patients in total, Device deficiencies will be recorded, including the description of the technical issue., start treatment (flushing) up to removal of drains, which is typically 12-24 hours after surgery|Efficacy: Occurance of drain occlusion, Having to permanently stop flushing as a result of retained fluid and no chest tube output. Patients with chest tube output until flushing is terminated and without retention that is not produced after flushing is terminated will by default not have occluded drains. It will be collected how many times the infusion was paused and/ or stopped due to fluid retention for each patient., start treatment (flushing) up to removal of drains, which is typically 12-24 hours after surgery