Coagulopathy During Cardiac Surgery
Conditions
Keywords
Coagulopathy, Hemorrhage, Cardiac surgery, Point-of-Care testing, POC, ROTEM, multiplate, Multiple electrode aggregometry (MEA)
Brief summary
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.
Interventions
DEVICEConventional laboratory testing (Central laboratory)
aPTT, INR, fibrinogen concentration, platelet count
DEVICEPOC testing
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)
Sponsors
Goethe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Step 1: * Patients scheduled for elective, complex cardiothoracic surgery (combined coronary artery bypass graft and valve surgery, double or triple valve procedures, aortic surgery or redo surgery) with cardiopulmonary bypass (CPB) Step 2: * diffuse bleeding after heparin reversal following extracorporeal circulation or * intra- or postoperative blood loss exceeding 250 ml/h or 50 ml/10 min
Exclusion criteria
* Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| packed red blood cell concentrate (PRBC) transfusion rate | During the period between inclusion into the study and 24 h after postoperative admission to ICU | Number of transfused units of PRBC during the period between inclusion into the study and 24 hours (h) after admission to ICU. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transfusion rate of Fresh Frozen Plasma | During the period between inclusion into the study and 24 h after postoperative admission to ICU | Number of transfused units of Fresh Frozen Plasma (FFP) |
| Postoperative Blood loss | for up to 24 h after postoperative admission to ICU | Blood loss 6h, 12h and 24h after postoperative admission to ICU |
| Duration of mechanical ventilation | after postoperative admission to ICU, an expected average of 30 hours | Duration of postoperative mechanical ventilation |
| Horovitz - indices | for up to 24 h after postoperative admission to ICU | PaO2/FiO2 - indices at admission to ICU, as well as 2h, 4h, 12h and 24 h after admission to ICU |
| Incidence of acute renal failure | during treatment at the intensive care unit, for an average of 3 weeks | Incidence of acute renal failure |
| Duration of hospitalisation | From admission to ICU and up to discharge from the hospital, an expected average of 10 days | duration of ICU treatment duration of IMC (Intermediate Care) treatment duration of hospitalisation |
| rethoracotomies | During the period between inclusion into the study and 24 h after postoperative admission to ICU | number of patients with rethoracotomies. Cause for rethoracotomies (surgical or coagulopathic bleeding, pericardium tamponade) |
| Thromboembolic or allergic adverse events | for up to 24 h after postoperative admission to ICU | Number of patients with thromboembolic or allergic adverse events. |
| Ventilator - associated pneumonia | after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days | Number of patients with ventilator - associated pneumonia |
| Postoperative Sepsis | after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days | Number of patients with postoperative Sepsis |
| Transfusion rate of platelet concentrates | During the period between inclusion into the study and 24 h after postoperative admission to ICU | Number of transfused platelet concentrates |
| Age of each platelet concentrate | During the period between inclusion into the study and 24 h after postoperative admission to ICU | age (days) of each platelet concentrates |
| Amount of infused PCC | During the period between inclusion into the study and 24 h after postoperative admission to ICU | Amount of infused prothrombin complex concentrates (PCC) |
| Amount of infused rVIIa | During the period between inclusion into the study and 24 h after postoperative admission to ICU | Amount of infused activated coagulation factor VII (rVIIa) |
| Amount of infused fibrinogen concentrate | During the period between inclusion into the study and 24 h after postoperative admission to ICU | Amount of infused fibrinogen concentrate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Preoperative antiaggregatory medication | at the day before surgery | number of patients with preoperative intake of any antiaggregatory medication. kind of antiaggregatory medication. |
| infused crystalloid and colloid volume | intraoperatively and for up to 24 h after admission to ICU | Amount of infused crystalloid and colloid volume. kind of crystalloid and colloid volume. |
| Age | at the day before surgery | age of the patient |
| euroSCORE | at the day before surgery | perioperative risk assessment |
| Weight | at the day before surgery | Weight of the patient |
| Height | at the day before surgery | height of the patient |
| ASA score | at the day before surgery | Preoperatively assessed anesthesia risk score |
| clamping time | intraoperatively | Duration of intraoperative clamping of the aorta |
| CPB time | intraoperatively | Duration of extracorporeal circulation intraoperatively |
| Priming volume | intraoperatively | Volume of the priming volume of the extracorporeal circulation |
| INR | preoperatively and up to 24 h after admission to ICU | International Normalized Ratio |
| aPTT | preoperatively and up to 24 h after admission to ICU | activated partial prothrombin time \[sec\] |
| Platelet count | preoperatively and up to 24 h after admission to ICU | platelet count |
| CT | Intraoperatively and up to 24 h after admission to ICU | Clotting time in the EXTEM and INTEM test of the Rotem device |
| MCF | intraoperatively and up to 24h after admission to ICU | Maximal clot firmness in the EXTEM- and INTEM test of the ROTEM device |
| AUC | intraoperatively and up to 24h after admission to ICU | Area under the aggregation curve in the Multiplate device following stimulation with arachidonic acid or adenosine disphosphate. |
Countries
Austria, Germany
Outcome results
None listed