The pericardial perfusie study, to evaluate the safety and feasability of postoperative pericardial perfusion with NaCl 0.9% to reduce blood loss after cardiac surgery

Excessive postoperative blood loss (>2L/24 hours or >200 mL/hour) is one of the
most common complications of cardiac surgery, and a risk factor for prolonged
mechanical ventilation, pneumonia, wound infection, sepsis, and mortality. A
surgical cause of bleeding is only found in half of patients undergoing
reoperation/re-exploration for bleeding. In the remainder of patients the cause
is multifactorial and probably an acquired/surgical related hemostatic defect
is responsible for diffuse, excessive blood loss.
During and a short period after cardiac surgery with concomitant usage of the
CPB primary hemostasis, coagulation, fibrinolysis, and inflammation are
activated. The addition of pericardial blood to the systemic circulation
strongly promote these processes, ultimately leading to a DIC process,
fibrinolysis and in some cases even increased blood loss. Allogeneic
transfusions of packed red cells are often required, with the risk of
transmitting infectious agents, provoking adverse immunologic reactions, and
increased mortality.

Postoperative pericardial perfusion with a crystalloid (NaCl 0.9%) to remove
the contaminated' pericardial blood, might reduce blood loss after cardiac
surgery.

The aim of this study is to evaluate the safety and feasibility of
postoperative pericardial perfusion with (prewarmed NaCl 0.9%) and the effect
of perfusion on blood loss after cardiac surgery.

Hypothesis
Pericardial perfusion with (prewarmed NaCl 0.9%) is safe and feasible and might
reduce blood loss after heart surgery

Pilot , intervention study to evaluate the feasibility and safety of
pericardial perfusion. Single center

Insertion of an extra (inflow) drain in the pericardium, over which NaCl 0.9%
will flow with an initial rate of 500mL/hour. The inflow will be ajusted
according to the outflow, with an one on one ratio. There will be continous
evaluation of in- and outflow.

The risk of the study is minor. Infection might be a possible adverse event,
due to an extra inserted drain, although the chance is limited by using one
incision for two drains (of which one is inserted regularly). To monitor this
possible adverse event, temperature and several laboratory measurements will be
determined. Fluid retention within the pleural and pericardial cavities will be
monitored via a radiologic and echographic imaging, and every opened
(pleural/pericardial) cavity is drained separately.

A possible benefit for a patient receiving the pericardial perfusion might be
active (central) warming when a patient suffers from hypothermia. The expected
decrease in blood loss and pericardial adhesions after operation, decreases the
change of reoperation and its complications.