Clinical trial NCT06521164: Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery
Official title: Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgical Blood Loss
Surgical Complication
Keywords: cardiac surgery
therapeutic irrigation
postoperative bleeding
chest tubes
Haermonics Pure System
Lead sponsor: Haermonics BV
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2024-07-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a prospective, single-arm, single-center clinical investigation of adult patients undergoing cardiac surgery. Safety and efficacy of CPPF, with and without the device, has been established in comparison with standard drainage. Therefore, this study is designed primarily to establish the usability of the device and its accessories, not requiring randomization against a control group.

Because the Haermonics Pure system and its accessories are used directly after surgery for several hours up to several days until drain removal before being discharged from the hospital, it is sufficient to follow patients until discharge from the cardiac surgery department. For patients with a prolonged hospitalization because of postoperative complications, it is considered sufficient to follow patients for 2 weeks after surgery because the impact of a pericardial flushing and postoperative drainage on outcomes is critical within the immediate postoperative period but limited beyond the time that the drains are removed. For device-related adverse events, follow-up will continue until the event is considered resolved or the patient is discharged.

Eligibility criteria: Inclusion Criteria:

1. Adult patients (≥18yrs and weight ≥40kg) undergoing cardiothoracic surgery (CABG and/or valve surgery, elective aortic surgery, Bentall procedure, ascending aorto/aortic arch replacement) with the use of cardiopulmonary bypass
2. Patient has been informed of the nature of the clinical investigation and is willing and able to give written informed consent for investigation participation

Exclusion Criteria:

1. Euroscore II \&gt; 20%
2. Emergent procedures
3. Complication during surgery which is life threatening and/or requires another surgical intervention
4. Minimal invasive cardiac surgery procedures (e.g. minithoracotomy and hemisternotomy)
5. Thoraco-abdominal surgery, or intraoperative injury to the diaphragm leading to an open connection between the thoracic and abdominal cavity
6. Participation in any study involving an investigational drug or device
7. Patient is pregnant or nursing
8. Inability to understand study information

Primary outcomes:
measure: Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.
timeFrame: for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.
measure: Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.
timeFrame: for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.
measure: Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.
timeFrame: 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 outcomes:
measure: Safety: Rate of device-related events up to discharge
timeFrame: From enrollment up to discharge or up to 2 weeks after surgery, whichever came first
measure: Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.
timeFrame: 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.
measure: Safety: Rate of SAEs up to discharge
timeFrame: From enrollment up to discharge or up to 2 weeks after surgery, whichever came first
measure: Efficacy: Drain fluid output 8 hours after start treatment (with sternum closed).
timeFrame: start treatment (flushing) up to 8 hours after start treatment (flushing).
measure: Technical Efficacy: Number of device deficiencies leading to permanently stopping the treatment for each patient, 65 patients in total
timeFrame: start treatment (flushing) up to removal of drains, which is typically 12-24 hours after surgery
measure: Efficacy: Occurance of drain occlusion
timeFrame: start treatment (flushing) up to removal of drains, which is typically 12-24 hours after surgery
Other outcomes:
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