Point-of-Care Testing in Coagulopathic Patients Undergoing Cardiac Surgery - a Multicenter Study
- Conditions
- Coagulopathy During Cardiac Surgery
- Registration Number
- NCT01826123
- Lead Sponsor
- Goethe University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
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
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Thromboembolic or allergic adverse events for up to 24 h after postoperative admission to ICU Number of patients with thromboembolic or allergic adverse events.
Duration of mechanical ventilation after postoperative admission to ICU, an expected average of 30 hours Duration of postoperative mechanical ventilation
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)
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
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)
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
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
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 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
Postoperative Blood loss for up to 24 h after postoperative admission to ICU Blood loss 6h, 12h and 24h after postoperative 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
Trial Locations
- Locations (4)
University of Linz
🇦🇹Linz, Oberösterreich, Austria
University of Heidelberg
🇩🇪Heidelberg, Baden Württemberg, Germany
Goethe - University
🇩🇪Frankfurt, Hessen, Germany
University of Rostock
🇩🇪Rostock, Mecklenburg Vorpommern, Germany
University of Linz🇦🇹Linz, Oberösterreich, Austria