Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery (USEPURE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Blood Loss; Surgical Complication
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lian van Lippen; Phone Number: 0031-625572304; Email: vanlippen@haermonics.com
• Study Contact Backup: Name: Stuart Head; Phone Number: 0031-645306042; Email: head@haermonics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 > 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: study subjects; 1-arm study	Device: Haermonics Pure system; pericardial flushing with Haermonics Pure system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 the System Usability Scale (SUS). It is comprised of 10 questions that should be answered on a 5-point Likert 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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Collaborators and Investigators

• Sponsor: Haermonics BV
• Collaborators: Avania

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: cardiac surgery; therapeutic irrigation; postoperative bleeding; chest tubes; Haermonics Pure System
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Skin Manifestations; Intraoperative Complications; Blood Loss, Surgical; Flushing
• Other Study ID Numbers: HX-2024-0047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No