Point-of-Care Testing in Coagulopathic Patients Undergoing Cardiac Surgery - a Multicenter Study

Study Overview
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Brief Summary
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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.

Official Title
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Point-of-Care Testing - A Prospective, Randomized, Controlled Multicenter Study of Efficacy in Coagulopathic Cardiac Surgery Patients

Conditions
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Coagulopathy During Cardiac Surgery

Intervention / Treatment
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* Device: Conventional laboratory testing (Central laboratory)
* Device: POC testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional laboratory testing<br>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. | Device: Conventional laboratory testing (Central laboratory)<br>* aPTT, INR, fibrinogen concentration, platelet count<br>|
| Active Comparator: POC testing (ROTEM and Multiplate)<br>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. | Device: POC testing<br>* 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)<br>* Other names: aggregometric measures using the Multiplate(R) device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhage, Coagulopathy, Cardiac surgery, Point-of-Care testing, POC, ROTEM, multiplate, Multiple electrode aggregometry (MEA)