Surgical Blood LossUSEPURENCT06521164
Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery
A study testing Haermonics Pure system in people with Surgical Blood Loss and Surgical Complication, run by Haermonics BV.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Blood Loss, Surgical Complication
- What is being tested?
- Haermonics Pure system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patient has been informed of the nature of the clinical investigation and is willing and able to give written informed consent for investigation participation
Who cannot join
- Euroscore II \> 20%
- Emergent procedures
- Complication during surgery which is life threatening and/or requires another surgical intervention
- Minimal invasive cardiac surgery procedures (e.g. minithoracotomy and hemisternotomy)
- Thoraco-abdominal surgery, or intraoperative injury to the diaphragm leading to an open connection between the thoracic and abdominal cavity
- Participation in any study involving an investigational drug or device
- Patient is pregnant or nursing
- Inability to understand study information
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Surgical Blood Loss, Surgical Complication
- Being tested
- Haermonics Pure system
- Keywords
- cardiac surgery, therapeutic irrigation, postoperative bleeding, chest tubes, Haermonics Pure System
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haermonics Pure systemDevice
pericardial flushing with Haermonics Pure system
| Study group | Role | What they receive |
|---|---|---|
| study subjects | Other | 1-arm study Receives: Device: Haermonics Pure system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 (6)
Safety: Rate of device-related events up to discharge
Descriptive statistics
Measured: From enrollment up to discharge or up to 2 weeks after surgery, whichever came first
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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: start treatment (flushing) up to removal of drains, which is typically 12-24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Oct 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Blood LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haermonics BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521164
- Sponsor's protocol ID
- HX-2024-0047
- Acronym
- USEPURE
- Status last verified
- Mar 2025
- First submitted
- 16 Jul 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06521164
- Acronym / sponsor ID
- USEPURE / HX-2024-0047
- Conditions
- Surgical Blood Loss, Surgical Complication
- Keywords
- cardiac surgery, therapeutic irrigation, postoperative bleeding, chest tubes, Haermonics Pure System
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Haermonics BVIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study subjects | Other | Device: Haermonics Pure system1-arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
- Patient has been informed of the nature of the clinical investigation and is willing and able to give written informed consent for investigation participation
Key exclusion criteria (8 listed)
- Euroscore II \> 20%
- Emergent procedures
- Complication during surgery which is life threatening and/or requires another surgical intervention
- Minimal invasive cardiac surgery procedures (e.g. minithoracotomy and hemisternotomy)
- Thoraco-abdominal surgery, or intraoperative injury to the diaphragm leading to an open connection between the thoracic and abdominal cavity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haermonics Pure systempericardial flushing with Haermonics Pure system | Device | study subjects |
Primary outcome
Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.
Time frame: for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.
For each user, questions will be asked about the common use of the Hearmonics Pure system using a 0-10 Numeric Rating Scale.
Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.
Time frame: for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.
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.
Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.
Time frame: for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.
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.
6 secondary outcomes
Safety: Rate of device-related events up to discharge
Time frame: From enrollment up to discharge or up to 2 weeks after surgery, whichever came first
Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.
Time frame: 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 SAEs up to discharge
Time frame: 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).
Time frame: 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
Time frame: start treatment (flushing) up to removal of drains, which is typically 12-24 hours after surgery
Efficacy: Occurance of drain occlusion
Time frame: start treatment (flushing) up to removal of drains, which is typically 12-24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Haermonics Pure system in people with Surgical Blood Loss and Surgical Complication, run by Haermonics BV.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lian van Lippen (0031-625572304, vanlippen@haermonics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.