Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05308589 |
| Other study ID # |
NL74428 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2, 2021 |
| Est. completion date |
April 18, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
