Recently, the investigators study group showed in a mono center study that Point of Care (POC) based hemotherapy may reduce transfusion rates of allogenic blood products in perioperative care of coagulopathic cardiac surgery patients. The investigators aim to verify the obtained results by conducting this multicenter study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
160
aPTT, INR, fibrinogen concentration, platelet count
ROTEM: Clotting time (CT) in the EXTEM- and INTEM-test, Maximal clot firmness in the FIBTEM-test, Clot Lysis Index (CLI) multiplate: Area under the aggregation curve following stimulation with arachidonic acid (ASA) and Adenosine diphosphate (ADP)
University of Linz
Linz, Upper Austria, Austria
University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Goethe - University
Frankfurt am Main, Hesse, Germany
University of Rostock
Rostock, Mecklenburg-Vorpommern, Germany
packed red blood cell concentrate (PRBC) transfusion rate
Number of transfused units of PRBC during the period between inclusion into the study and 24 hours (h) after admission to ICU.
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Transfusion rate of Fresh Frozen Plasma
Number of transfused units of Fresh Frozen Plasma (FFP)
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Postoperative Blood loss
Blood loss 6h, 12h and 24h after postoperative admission to ICU
Time frame: for up to 24 h after postoperative admission to ICU
Duration of mechanical ventilation
Duration of postoperative mechanical ventilation
Time frame: after postoperative admission to ICU, an expected average of 30 hours
Horovitz - indices
PaO2/FiO2 - indices at admission to ICU, as well as 2h, 4h, 12h and 24 h after admission to ICU
Time frame: for up to 24 h after postoperative admission to ICU
Incidence of acute renal failure
Incidence of acute renal failure
Time frame: during treatment at the intensive care unit, for an average of 3 weeks
Duration of hospitalisation
duration of ICU treatment duration of IMC (Intermediate Care) treatment duration of hospitalisation
Time frame: From admission to ICU and up to discharge from the hospital, an expected average of 10 days
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rethoracotomies
number of patients with rethoracotomies. Cause for rethoracotomies (surgical or coagulopathic bleeding, pericardium tamponade)
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Thromboembolic or allergic adverse events
Number of patients with thromboembolic or allergic adverse events.
Time frame: for up to 24 h after postoperative admission to ICU
Ventilator - associated pneumonia
Number of patients with ventilator - associated pneumonia
Time frame: after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days
Postoperative Sepsis
Number of patients with postoperative Sepsis
Time frame: after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days
Transfusion rate of platelet concentrates
Number of transfused platelet concentrates
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Age of each platelet concentrate
age (days) of each platelet concentrates
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Amount of infused PCC
Amount of infused prothrombin complex concentrates (PCC)
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Amount of infused rVIIa
Amount of infused activated coagulation factor VII (rVIIa)
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Amount of infused fibrinogen concentrate
Amount of infused fibrinogen concentrate
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU