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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional laboratory testing | Active Comparator | After being randomized to the group "conventional coagulating testing", hemostatic therapy will be based exclusively on conventional standard coagulation analyses like International normalized ratio (INR), activated prothrombin time (aPTT), fibrinogen and platelet concentration or Activated clotting time (ACT. Analyses will be performed at i) fixed time points (preoperative and at admission to ICU) and ii) variable timepoints depending on the decision of the attending physician. Hemostatic therapy will be based on a specific hemostatic therapy algorithm. Intraoperatively, analyses of ACT (activated clotting time) and INR will be performed following institutional standards using specific POC tests. |
|
| POC testing (ROTEM and Multiplate) | Active Comparator | After being randomized to the group "POC testing", hemostatic therapy will be based exclusively on POC measures obtained by i) viscoelastic tests (ROTEM(R), TEM international, Munich, Germany) and aggregometric tests (multiplate, ROCHE AG, Grenzach, Germany). Analyses will be performed at variable timepoints depending on the decision of the attending physician. Hemostatic therapy will be based on a specific hemostatic therapy algorithm. Intraoperatively, analyses of ACT (activated clotting time) and INR will be performed following institutional standards using specific POC tests. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional laboratory testing (Central laboratory) | Device | aPTT, INR, fibrinogen concentration, platelet count |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the period between inclusion into the study and 24 h after postoperative admission to ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion rate of Fresh Frozen Plasma | Number of transfused units of Fresh Frozen Plasma (FFP) | During the period between inclusion into the study and 24 h after postoperative admission to ICU |
| Postoperative Blood loss |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative antiaggregatory medication | number of patients with preoperative intake of any antiaggregatory medication. kind of antiaggregatory medication. | at the day before surgery |
| infused crystalloid and colloid volume |
Inclusion Criteria:
Step 1:
Step 2:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian F Weber, MD | Goethe University | Study Director |
| Kai Zacharowski, PhD, MD | Goethe University | Principal Investigator |
| Alexander Schellhaaß, MD | Heidelberg University | Study Chair |
| Stefan Hofer, PhD, MD | Heidelberg University | Study Chair |
| Roland Freynschlag, MD | University of Linz | Study Chair |
| Hans Gombotz, PhD, MD | University of Linz | Study Chair |
| Jan Roesner, MD | University of Rostock | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Linz | Linz | Upper Austria | 4010 | Austria | ||
| University of Heidelberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22914710 | Background | Weber CF, Gorlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012 Sep;117(3):531-47. doi: 10.1097/ALN.0b013e318264c644. | |
| 22685493 | Background |
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| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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| POC testing | Device | 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) |
|
|
Blood loss 6h, 12h and 24h after postoperative admission to ICU
| for up to 24 h after postoperative admission to ICU |
| Duration of mechanical ventilation | Duration of postoperative mechanical ventilation | 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 | for up to 24 h after postoperative admission to ICU |
| Incidence of acute renal failure | Incidence of acute renal failure | 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 | From admission to ICU and up to discharge from the hospital, an expected average of 10 days |
| rethoracotomies | number of patients with rethoracotomies. Cause for rethoracotomies (surgical or coagulopathic bleeding, pericardium tamponade) | 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. | for up to 24 h after postoperative admission to ICU |
| Ventilator - associated pneumonia | Number of patients with ventilator - associated pneumonia | after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days |
| Postoperative Sepsis | Number of patients with postoperative Sepsis | 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 | 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 | 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) | 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) | 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 | During the period between inclusion into the study and 24 h after postoperative admission to ICU |
Amount of infused crystalloid and colloid volume. kind of crystalloid and colloid volume.
| intraoperatively and for up to 24 h after admission to ICU |
| Age | age of the patient | at the day before surgery |
| euroSCORE | perioperative risk assessment | at the day before surgery |
| Weight | Weight of the patient | at the day before surgery |
| Height | height of the patient | at the day before surgery |
| ASA score | Preoperatively assessed anesthesia risk score | at the day before surgery |
| clamping time | Duration of intraoperative clamping of the aorta | intraoperatively |
| CPB time | Duration of extracorporeal circulation intraoperatively | intraoperatively |
| Priming volume | Volume of the priming volume of the extracorporeal circulation | intraoperatively |
| INR | International Normalized Ratio | preoperatively and up to 24 h after admission to ICU |
| aPTT | activated partial prothrombin time [sec] | preoperatively and up to 24 h after admission to ICU |
| Platelet count | platelet count | preoperatively and up to 24 h after admission to ICU |
| CT | Clotting time in the EXTEM and INTEM test of the Rotem device | Intraoperatively and up to 24 h after admission to ICU |
| MCF | Maximal clot firmness in the EXTEM- and INTEM test of the ROTEM device | intraoperatively and up to 24h after admission to ICU |
| AUC | Area under the aggregation curve in the Multiplate device following stimulation with arachidonic acid or adenosine disphosphate. | intraoperatively and up to 24h after admission to ICU |
| Heidelberg |
| Baden-Wurttemberg |
| 69120 |
| Germany |
| Goethe - University | Frankfurt am Main | Hesse | 60590 | Germany |
| University of Rostock | Rostock | Mecklenburg-Vorpommern | 18051 | Germany |
| Weber CF, Zacharowski K. Perioperative point of care coagulation testing. Dtsch Arztebl Int. 2012 May;109(20):369-75. doi: 10.3238/arztebl.2012.0369. Epub 2012 May 18. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |