Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Haermonics Pure system.
- Who it may be relevant to
- Registry conditions: Surgical Blood Loss, Surgical Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Haermonics Pure system
pericardial flushing with 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. [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. [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. [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.]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06521164 · HX-2024-0047