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

Primary Purpose

Coagulopathy During Cardiac Surgery

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Conventional laboratory testing (Central laboratory)
POC testing
Sponsored by
Goethe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coagulopathy During Cardiac Surgery focused on measuring Coagulopathy, Hemorrhage, Cardiac surgery, Point-of-Care testing, POC, ROTEM, multiplate, Multiple electrode aggregometry (MEA)

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Linz
  • University of Heidelberg
  • Goethe - University
  • University of Rostock

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional laboratory testing

POC testing (ROTEM and Multiplate)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Transfusion rate of Fresh Frozen Plasma
Number of transfused units of Fresh Frozen Plasma (FFP)
Postoperative Blood loss
Blood loss 6h, 12h and 24h after postoperative admission to ICU
Duration of mechanical ventilation
Duration of postoperative mechanical ventilation
Horovitz - indices
PaO2/FiO2 - indices at admission to ICU, as well as 2h, 4h, 12h and 24 h after admission to ICU
Incidence of acute renal failure
Incidence of acute renal failure
Duration of hospitalisation
duration of ICU treatment duration of IMC (Intermediate Care) treatment duration of hospitalisation
rethoracotomies
number of patients with rethoracotomies. Cause for rethoracotomies (surgical or coagulopathic bleeding, pericardium tamponade)
Thromboembolic or allergic adverse events
Number of patients with thromboembolic or allergic adverse events.
Ventilator - associated pneumonia
Number of patients with ventilator - associated pneumonia
Postoperative Sepsis
Number of patients with postoperative Sepsis
Transfusion rate of platelet concentrates
Number of transfused platelet concentrates
Age of each platelet concentrate
age (days) of each platelet concentrates
Amount of infused PCC
Amount of infused prothrombin complex concentrates (PCC)
Amount of infused rVIIa
Amount of infused activated coagulation factor VII (rVIIa)
Amount of infused fibrinogen concentrate
Amount of infused fibrinogen concentrate

Full Information

First Posted
March 19, 2013
Last Updated
May 3, 2017
Sponsor
Goethe University
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1. Study Identification

Unique Protocol Identification Number
NCT01826123
Brief Title
Point-of-Care Testing in Coagulopathic Patients Undergoing Cardiac Surgery - a Multicenter Study
Acronym
MultiPOC
Official Title
Point-of-Care Testing - A Prospective, Randomized, Controlled Multicenter Study of Efficacy in Coagulopathic Cardiac Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coagulopathy During Cardiac Surgery
Keywords
Coagulopathy, Hemorrhage, Cardiac surgery, Point-of-Care testing, POC, ROTEM, multiplate, Multiple electrode aggregometry (MEA)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional laboratory testing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
POC testing (ROTEM and Multiplate)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional laboratory testing (Central laboratory)
Intervention Description
aPTT, INR, fibrinogen concentration, platelet count
Intervention Type
Device
Intervention Name(s)
POC testing
Other Intervention Name(s)
viscoleastic measures using the ROTEM(R) device and, aggregometric measures using the Multiplate(R) device
Intervention Description
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)
Primary Outcome Measure Information:
Title
packed red blood cell concentrate (PRBC) transfusion rate
Description
Number of transfused units of PRBC during the period between inclusion into the study and 24 hours (h) after admission to ICU.
Time Frame
During the period between inclusion into the study and 24 h after postoperative admission to ICU
Secondary Outcome Measure Information:
Title
Transfusion rate of Fresh Frozen Plasma
Description
Number of transfused units of Fresh Frozen Plasma (FFP)
Time Frame
During the period between inclusion into the study and 24 h after postoperative admission to ICU
Title
Postoperative Blood loss
Description
Blood loss 6h, 12h and 24h after postoperative admission to ICU
Time Frame
for up to 24 h after postoperative admission to ICU
Title
Duration of mechanical ventilation
Description
Duration of postoperative mechanical ventilation
Time Frame
after postoperative admission to ICU, an expected average of 30 hours
Title
Horovitz - indices
Description
PaO2/FiO2 - indices at admission to ICU, as well as 2h, 4h, 12h and 24 h after admission to ICU
Time Frame
for up to 24 h after postoperative admission to ICU
Title
Incidence of acute renal failure
Description
Incidence of acute renal failure
Time Frame
during treatment at the intensive care unit, for an average of 3 weeks
Title
Duration of hospitalisation
Description
duration of ICU treatment duration of IMC (Intermediate Care) treatment duration of hospitalisation
Time Frame
From admission to ICU and up to discharge from the hospital, an expected average of 10 days
Title
rethoracotomies
Description
number of patients with rethoracotomies. Cause for rethoracotomies (surgical or coagulopathic bleeding, pericardium tamponade)
Time Frame
During the period between inclusion into the study and 24 h after postoperative admission to ICU
Title
Thromboembolic or allergic adverse events
Description
Number of patients with thromboembolic or allergic adverse events.
Time Frame
for up to 24 h after postoperative admission to ICU
Title
Ventilator - associated pneumonia
Description
Number of patients with ventilator - associated pneumonia
Time Frame
after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days
Title
Postoperative Sepsis
Description
Number of patients with postoperative Sepsis
Time Frame
after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days
Title
Transfusion rate of platelet concentrates
Description
Number of transfused platelet concentrates
Time Frame
During the period between inclusion into the study and 24 h after postoperative admission to ICU
Title
Age of each platelet concentrate
Description
age (days) of each platelet concentrates
Time Frame
During the period between inclusion into the study and 24 h after postoperative admission to ICU
Title
Amount of infused PCC
Description
Amount of infused prothrombin complex concentrates (PCC)
Time Frame
During the period between inclusion into the study and 24 h after postoperative admission to ICU
Title
Amount of infused rVIIa
Description
Amount of infused activated coagulation factor VII (rVIIa)
Time Frame
During the period between inclusion into the study and 24 h after postoperative admission to ICU
Title
Amount of infused fibrinogen concentrate
Description
Amount of infused fibrinogen concentrate
Time Frame
During the period between inclusion into the study and 24 h after postoperative admission to ICU
Other Pre-specified Outcome Measures:
Title
Preoperative antiaggregatory medication
Description
number of patients with preoperative intake of any antiaggregatory medication. kind of antiaggregatory medication.
Time Frame
at the day before surgery
Title
infused crystalloid and colloid volume
Description
Amount of infused crystalloid and colloid volume. kind of crystalloid and colloid volume.
Time Frame
intraoperatively and for up to 24 h after admission to ICU
Title
Age
Description
age of the patient
Time Frame
at the day before surgery
Title
euroSCORE
Description
perioperative risk assessment
Time Frame
at the day before surgery
Title
Weight
Description
Weight of the patient
Time Frame
at the day before surgery
Title
Height
Description
height of the patient
Time Frame
at the day before surgery
Title
ASA score
Description
Preoperatively assessed anesthesia risk score
Time Frame
at the day before surgery
Title
clamping time
Description
Duration of intraoperative clamping of the aorta
Time Frame
intraoperatively
Title
CPB time
Description
Duration of extracorporeal circulation intraoperatively
Time Frame
intraoperatively
Title
Priming volume
Description
Volume of the priming volume of the extracorporeal circulation
Time Frame
intraoperatively
Title
INR
Description
International Normalized Ratio
Time Frame
preoperatively and up to 24 h after admission to ICU
Title
aPTT
Description
activated partial prothrombin time [sec]
Time Frame
preoperatively and up to 24 h after admission to ICU
Title
Platelet count
Description
platelet count
Time Frame
preoperatively and up to 24 h after admission to ICU
Title
CT
Description
Clotting time in the EXTEM and INTEM test of the Rotem device
Time Frame
Intraoperatively and up to 24 h after admission to ICU
Title
MCF
Description
Maximal clot firmness in the EXTEM- and INTEM test of the ROTEM device
Time Frame
intraoperatively and up to 24h after admission to ICU
Title
AUC
Description
Area under the aggregation curve in the Multiplate device following stimulation with arachidonic acid or adenosine disphosphate.
Time Frame
intraoperatively and up to 24h after admission to ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian F Weber, MD
Organizational Affiliation
Goethe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kai Zacharowski, PhD, MD
Organizational Affiliation
Goethe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Schellhaaß, MD
Organizational Affiliation
Heidelberg University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stefan Hofer, PhD, MD
Organizational Affiliation
Heidelberg University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roland Freynschlag, MD
Organizational Affiliation
University of Linz
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hans Gombotz, PhD, MD
Organizational Affiliation
University of Linz
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jan Roesner, MD
Organizational Affiliation
University of Rostock
Official's Role
Study Chair
Facility Information:
Facility Name
University of Linz
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
University of Heidelberg
City
Heidelberg
State/Province
Baden Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Goethe - University
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
University of Rostock
City
Rostock
State/Province
Mecklenburg Vorpommern
ZIP/Postal Code
18051
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22914710
Citation
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.
Results Reference
background
PubMed Identifier
22685493
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.
Results Reference
background

Learn more about this trial

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

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