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CPPF After Cardiac Surgery in High Risk Patients (FLUID)

Primary Purpose

Cardiac Surgical Procedures, Retained Blood Syndrome, Cardiac Tamponade

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
CPPF
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Surgical Procedures focused on measuring Continuous Postoperative Pericardial Flush (CPPF), CABG, Retained Blood Syndrome, Chest tubes [Mesh], Blood Transfusion [mesh], Therapeutic irrigation [Mesh]

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for CABG with continued DAPT
  • Patients with aIE scheduled for valve replacement
  • Patients scheduled for complex or multiple cardiac (redo) procedures with an (expected) CPB time >300 minutes
  • Patients undergoing aortic surgery with DHCA

Exclusion Criteria:

  • Euroscore II > 20%
  • Intraoperatively diaphragm injury leading to an open connection between the thoracic and abdominal cavity
  • Age < 18
  • Inability to understand study information
  • Participation in any study involving an investigational drug or device

Exclusion criteria specific for the CABG group include:

  • Emergency CABG
  • Single anti-platelet medication
  • Off pump surgery

Exclusion criteria specific for the IE group include:

• Subacute or chronic endocarditis: no signs of ongoing infection under AB treatment.

Exclusion criteria specific for the aortic surgery group include:

  • Emergency procedures
  • Isolated ascending aorta replacement

Sites / Locations

  • Amsterdam UMC
  • Catharina Ziekenhuis
  • Leiden University Medical Center
  • St. Antonius Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Continuous Postoperative Pericardial Flushing

Control

Arm Description

Continuous Postoperative Pericardial Flushing (inflow of 500 ml NaCl 0,9% flushing fluid into the pericardial cavity during the first 8 postoperative hours) executed with the Haermonics investigational device

Standard care

Outcomes

Primary Outcome Measures

Incidence of re-exploration
The incidence of re-exploration for either cardiac tamponade and/or excessive bleeding due to non-surgical bleeding.

Secondary Outcome Measures

To assess safety and feasibility of the Haermonics investigational device
Incidence of treatment related serious Adverse Events
Hct-sensor validation
comparibility of the hct values of the chest drain volume measured by the Haermonics investigational device (hourly during the first 10 hours in the ICU and at chest tube removal) and hct values of chest drain samples (drawn from the outflow tube during the first 10 hours in the ICU and at chest tube removal) performed by the local laboratory.
Number of participants with new onset postoperative fibrillation requiring medical therapy or electrocardioversion (ECV)
incidence of new onset postoperative fibrillation requiring medical therapy or electrocardioversion (ECV)
To investigate the clinical effects of CPPF on the use of blood products and administration of coagulation factors
Number of participants that reveived blood products and/or coagulation factors
To investigate the clinical effects of CPPF on the use of blood products and administration of coagulation factors
Number of units per patients
To investigate the clinical effects of CPPF on ICU and hospital stay
ICU stay (hours) and hospital stay (days)

Full Information

First Posted
February 28, 2022
Last Updated
July 20, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Haermonics, European Regional Development Fund
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1. Study Identification

Unique Protocol Identification Number
NCT05308589
Brief Title
CPPF After Cardiac Surgery in High Risk Patients
Acronym
FLUID
Official Title
Continuous Postoperative Pericardial Flushing After General Cardiac Surgery Procedures With the Haermonics Investigational Device: Study Protocol of the FLUID (FLUsh With Investigational Device) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
The study no longer fits our strategic goals. The preliminary results of FLUID have led to an improved version of the current device. We believe it is necessary to initiate a new study, with the improved version of the device.
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
April 18, 2023 (Actual)
Study Completion Date
April 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Haermonics, European Regional Development Fund

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In two randomized clinical trials the investigators have demonstrated that continuous postoperative pericardial flushing (CPPF) therapy can reduce postoperative blood loss and bleeding-related complications after cardiac surgery and that CPPF therapy is safe and feasible in an experimental setting. The Haermonics investigational device is a novel medical device that enables CPPF therapy to be used in daily clinical setting. The aim of this study is three-fold. First, to evaluate the safety and functionality of the Haermonics investigational device. Secondly, to investigate the effect of CPPF therapy on bleeding related complications in the adulty cardiac surgery population. Thirdly, to explore the effect of CPPF therapy on intraluminal chest tube clogging.
Detailed Description
CPPF therapy Prolonged or excessive bleeding after cardiac surgery can lead to a broad spectrum of secondary complications. One of the underlying causes is incomplete wound drainage, with subsequent accumulation of blood and clots in the pericardium. It has been demonstrated that this retained blood and clots lead to even more fibrinolytic activity in the mediastinum and pericardial space, and therefore may contribute to increased or prolonged bleeding. Based on this principle, the method of continuous postoperative pericardial flushing (CPPF) has been invented and further developed. The hypothesis is that CPPF therapy works by mechanical cleaning properties and by diminishing fibrinolysis and inflammation. The CPPF protocol includes the inflow of NaCl 0,9% flushing fluid into the pericardial cavity during the first postoperative hours in patients who underwent cardiac surgery. In this way, the blood and clot mixture can be diluted into a lower viscosity solution, thereby enhancing the evacuation of blood and clots from the pericardial space and preventing chest tube obstruction. The Haermonics investigational device Because CPPF therapy includes the dilution of the normal postoperative mediastinal chest tube drainage (MCTD), the clinical assessment of the exact amount of blood loss is more difficult. Yet, blood loss is an important factor in clinical decision making, namely the decision if the patient needs a surgical re-exploration for postoperative bleeding or not. Roughly, in patients who receive CPPF therapy, blood loss can be estimated by extracting the total inflow flushing volume from the total MCTD. This method was used in the experimental setting of the previous CPPF trails but is considered unsuitable for use in daily practice because of three reasons. First, the required registration of in- and outflow volume is labour intensive. Secondly, because this registration can only be done intermittently, which can be dangerous in case of a fast bleeding rate. Thirdly, blood loss calculation could potentially be inaccurate because sometimes, clinically insignificant, amounts of flushing fluid are retained or absorbed in the pericardial or pleural spaces, thereby making the blood loss calculation inaccurate. The first commercial Haermonics device will have four essential functionalities that make CPPF therapy safe and feasible for daily clinical use. 1) Automatic monitoring of the outflow volume, 2) Quantification of the content of the outflow volume by means of real time and continuous haematocrit (hct) analysis of the MCTD, 3) Warming of the flushing fluid to body temperature and temperature measurements of the flushing fluid, and 4) Continuous intrapericardial pressure measurement. The investigational device that will be used in this study will have all these functionalities, but available data will not be used for clinical decision making yet. Previous studies CPPF, executed with a researcher instead of a medical device, has been investigated in two randomized clinical trials. The CPPF protocol included the inflow of 500 ml NaCl 0,9% flushing fluid into the pericardial cavity during the first 12 postoperative hours in patients who underwent cardiac surgery. In this way, the blood and clot mixture were diluted into a lower viscosity solution, thereby enhancing the evacuation of blood and clots from the pericardial space and preventing chest tube obstruction. In two distinct cardiac surgery populations, both trials showed CPPF led to a statistically significant reduction in the primary outcome, i.e., blood loss, while pooled data showed a statistically significant difference for the clinically most relevant secondary end points, like the incidence of re-interventions for either non-surgical bleeding and/or acute cardiac tamponade (0 vs. 8 in CPPF vs. control group). The present study is powered to assess the effects of CPPF, executed by the Haermonics investigational device, in comparison with standard care on these clinically more relevant endpoints in a population of adult cardiac surgery patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgical Procedures, Retained Blood Syndrome, Cardiac Tamponade, Postoperative Hemorrhage
Keywords
Continuous Postoperative Pericardial Flush (CPPF), CABG, Retained Blood Syndrome, Chest tubes [Mesh], Blood Transfusion [mesh], Therapeutic irrigation [Mesh]

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Postoperative Pericardial Flushing
Arm Type
Experimental
Arm Description
Continuous Postoperative Pericardial Flushing (inflow of 500 ml NaCl 0,9% flushing fluid into the pericardial cavity during the first 8 postoperative hours) executed with the Haermonics investigational device
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Device
Intervention Name(s)
CPPF
Intervention Description
Continuous Postoperative Pericardial Flush
Primary Outcome Measure Information:
Title
Incidence of re-exploration
Description
The incidence of re-exploration for either cardiac tamponade and/or excessive bleeding due to non-surgical bleeding.
Time Frame
30 day
Secondary Outcome Measure Information:
Title
To assess safety and feasibility of the Haermonics investigational device
Description
Incidence of treatment related serious Adverse Events
Time Frame
8 hours
Title
Hct-sensor validation
Description
comparibility of the hct values of the chest drain volume measured by the Haermonics investigational device (hourly during the first 10 hours in the ICU and at chest tube removal) and hct values of chest drain samples (drawn from the outflow tube during the first 10 hours in the ICU and at chest tube removal) performed by the local laboratory.
Time Frame
8 hours
Title
Number of participants with new onset postoperative fibrillation requiring medical therapy or electrocardioversion (ECV)
Description
incidence of new onset postoperative fibrillation requiring medical therapy or electrocardioversion (ECV)
Time Frame
3 months
Title
To investigate the clinical effects of CPPF on the use of blood products and administration of coagulation factors
Description
Number of participants that reveived blood products and/or coagulation factors
Time Frame
3 months
Title
To investigate the clinical effects of CPPF on the use of blood products and administration of coagulation factors
Description
Number of units per patients
Time Frame
3 months
Title
To investigate the clinical effects of CPPF on ICU and hospital stay
Description
ICU stay (hours) and hospital stay (days)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
To assess cost-effectiveness
Description
costs per QALY gained using the EQ-5D
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In order to be eligible to participate in this study, a subject should be scheduled for a general cardiothoracic surgery procedure with the use of cardiopulmonary bypass, amongst others, the main categories are; Coronary artery bypass grafting (CABG), Valve surgery, CABG combined with valve surgery Elective patients scheduled for aortic surgery (including valve sparing root replacement (VSRR), Bentall procedures, ascending aorta- aortic arch replacement) Including the initial study population: Patients scheduled for CABG with continued DAPT Patients with aIE scheduled for valve replacement Patients scheduled for complex or multiple cardiac (redo) procedures with an (expected) CPB time >300 minutes Patients undergoing aortic surgery with DHCA Exclusion Criteria: Euroscore II > 20% Intraoperatively diaphragm injury leading to an open connection between the thoracic and abdominal cavity Age < 18 Inability to understand study information Participation in any study involving an investigational drug or device Emergent procedures Procedures performed off pump, without the use of cardiopulmonary bypass. Minimal invasive cardiac surgery procedures (e.g. minithoracotomy and hemisternotomy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Klautz, Prof
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC
City
Amsterdam
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

CPPF After Cardiac Surgery in High Risk Patients

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