CONTINUOUS POSTOPERATIVE PERICARDIAL FLUSHING AFTER GENERAL CARDIAC SURGERY PROCEDURES WITH THE HAERMONICS INVESTIGATIONAL DEVICE : STUDY PROTOCOL OF THE FLUID (FLUsh with Investigational Device) TRIAL

Excessive blood loss after open heart surgery is one of the most common causes
of complications after thoracic surgery. If excessive blood loss is observed
after open surgery, the patient sometimes has to go back to the OR to find the
root cause of the bleeding. Sometimes, a clear cause is found and can be solved
with an extra stitch, however, often there is a diffuse bloos loss: small
bleedings spread in the whole wound bed.

Earlier research has shown that excessive blood loss significantly reduces if
the wound bed is irrigated with warm saline directly at the end of the thoracic
procedure and the following 12 hours (CPPF). There is less accumulation of
blood and clots in the wound.
During studies, blood loss appeared to be reduced signigicantly for those
patients treated with continuous postoperative pericardial flushing (CPPF)
compared to the standard drainage method. In the CPPF group, no reopoerations
were needed, whilst this occured 8 times in the control group. Thhis difference
supports the theory that CPPF prevents complications. We can conclude that CPPF
is a safe and effective way to reduce blood loss after thoracic surgery.

The primary objective of this study is to assess the effects of CPPF, executed
by Haermonics Flush, in comparison with standard care on clinically relevant
endpoints, like re-explorations, in a population of cardiac surgery patients
that have an increased risk for postoperative bleeding. Secondary objectives
are to assess the safety and feasibility of a newly developed CPPF device,
i.e., the Haermonics Flush, to validate the hct-sensor and to investigate the
effect of CPPF on blood loss, coagulation and fibrinolysis. Thirdly, to explore
the effect of CPPF therapy on intraluminal chest tube clogging.

This is a prospective, multicenter, open label, adaptive, randomized clincal
trial.

One group receives CPPF therapy (inflow of 500 ml NaCl 0,9% flushing fluid into
the pericardial cavity during the first 8 postoperative hours) executed with
the Haermonics Flush investigational device) and the other group receives
standard care.

The extra risk or burden for patients is minimal. Those patients who will be
included in the CPPF group, will receive an extra incision for the placement of
the inflow tube. An infection as a consequence of this extra incision is a
possible complication, however we have not see any evidence for this in earlier
studies (about 185 patients flushed).
Remaining infusion fluids is another possible complication; earlier studies
have proven that the chance on occluded drains (with the consequence of
accumulating blood and fluids in the pericard) is smaller when CPPF is applied.
Moreover, in the studies performed so far, no evidence have been found for any
residual fluids, also not when patients were scanned radiologically and
echographic. On the contrary, there were less interventions for residual blood
and fluids in the CPPF group.

The drawing of blood samples will, to our expectance, not increase the risk of
the patients included.