Coagulopathy During Cardiac Surgery Clinical Trial
— MultiPOCOfficial title:
Point-of-Care Testing - A Prospective, Randomized, Controlled Multicenter Study of Efficacy in Coagulopathic Cardiac Surgery Patients
| Verified date | May 2017 |
| Source | Goethe University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 160 |
| Est. completion date | May 2019 |
| Est. primary completion date | May 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | University of Linz | Linz | Oberösterreich |
| Germany | Goethe - University | Frankfurt | Hessen |
| Germany | University of Heidelberg | Heidelberg | Baden Württemberg |
| Germany | University of Rostock | Rostock | Mecklenburg Vorpommern |
| Lead Sponsor | Collaborator |
|---|---|
| Goethe University |
Austria, Germany,
Weber CF, Görlinger 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. — View Citation
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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Preoperative antiaggregatory medication | number of patients with preoperative intake of any antiaggregatory medication. kind of antiaggregatory medication. | at the day before surgery | |
| Other | infused crystalloid and colloid volume | Amount of infused crystalloid and colloid volume. kind of crystalloid and colloid volume. | intraoperatively and for up to 24 h after admission to ICU | |
| Other | Age | age of the patient | at the day before surgery | |
| Other | euroSCORE | perioperative risk assessment | at the day before surgery | |
| Other | Weight | Weight of the patient | at the day before surgery | |
| Other | Height | height of the patient | at the day before surgery | |
| Other | ASA score | Preoperatively assessed anesthesia risk score | at the day before surgery | |
| Other | clamping time | Duration of intraoperative clamping of the aorta | intraoperatively | |
| Other | CPB time | Duration of extracorporeal circulation intraoperatively | intraoperatively | |
| Other | Priming volume | Volume of the priming volume of the extracorporeal circulation | intraoperatively | |
| Other | INR | International Normalized Ratio | preoperatively and up to 24 h after admission to ICU | |
| Other | aPTT | activated partial prothrombin time [sec] | preoperatively and up to 24 h after admission to ICU | |
| Other | Platelet count | platelet count | preoperatively and up to 24 h after admission to ICU | |
| Other | CT | Clotting time in the EXTEM and INTEM test of the Rotem device | Intraoperatively and up to 24 h after admission to ICU | |
| Other | MCF | Maximal clot firmness in the EXTEM- and INTEM test of the ROTEM device | intraoperatively and up to 24h after admission to ICU | |
| Other | 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 | |
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | Postoperative Blood loss | Blood loss 6h, 12h and 24h after postoperative admission to ICU | for up to 24 h after postoperative admission to ICU | |
| Secondary | Duration of mechanical ventilation | Duration of postoperative mechanical ventilation | after postoperative admission to ICU, an expected average of 30 hours | |
| Secondary | 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 | |
| Secondary | Incidence of acute renal failure | Incidence of acute renal failure | during treatment at the intensive care unit, for an average of 3 weeks | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Thromboembolic or allergic adverse events | Number of patients with thromboembolic or allergic adverse events. | for up to 24 h after postoperative admission to ICU | |
| Secondary | 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 | |
| Secondary | Postoperative Sepsis | Number of patients with postoperative Sepsis | after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |