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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coagulopathy During Cardiac Surgery
• Intervention / Treatment: Device: Conventional laboratory testing (Central laboratory); Device: POC testing

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4010
      • University of Linz
• Germany
  • Baden Württemberg
    • Heidelberg, Baden Württemberg, Germany, 69120
      • University of Heidelberg
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Goethe - University
  • Mecklenburg Vorpommern
    • Rostock, Mecklenburg Vorpommern, Germany, 18051
      • University of Rostock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional laboratory testing; 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); aPTT, INR, fibrinogen concentration, platelet count
Active Comparator: POC testing (ROTEM and Multiplate); 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; 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); Other Names: viscoleastic measures using the ROTEM(R) device and; aggregometric measures using the Multiplate(R) device

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Goethe University
• Investigators: Study Director: Christian F Weber, MD, Goethe University; Principal Investigator: Kai Zacharowski, PhD, MD, Goethe University; Study Chair: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: April 3, 2013
• First Posted (Estimate): April 8, 2013

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Hemorrhage; Cardiac surgery; ROTEM; multiplate; Coagulopathy; Point-of-Care testing; POC; Multiple electrode aggregometry (MEA)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: 343/12