An interventional study of Haermonics Pure system in Surgical Blood Loss and Surgical Complication, sponsored by Haermonics BV. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Haermonics BV · Not applicable, Interventional, and Treatment
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.
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.
213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
This study's planned enrollment of 65 is below the median of 80 across 160 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →This is the only study on the registry with Haermonics BV as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1-arm study
Device: Haermonics Pure system
pericardial flushing with Haermonics Pure system
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.
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.
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.
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.
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.
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.
Safety: Rate of device-related events up to discharge
Descriptive statistics
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.
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.
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
Relationship with the device will be determined for all SAEs. All events of reoperations, pericardiocetesis and pleurcentesis are considered to be SAEs.
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).
Total amount of fluid output, comparing this with the historical control established in the previous FLUID trial.
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
Device deficiencies will be recorded, including the description of the technical issue.
Time frame: 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.
Time frame: start treatment (flushing) up to removal of drains, which is typically 12-24 hours after surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2025; primary completion for May 2026, 7 months later.
Of 40 interventional studies with no phase under Blood Loss, Surgical, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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