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

May 3, 2017 updated by: Christian F. Weber, MD, Goethe University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
packed red blood cell concentrate (PRBC) transfusion rate
Time Frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Transfusion rate of Fresh Frozen Plasma
Time Frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
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
Time Frame: for up to 24 h after postoperative admission to ICU
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
Time Frame: after postoperative admission to ICU, an expected average of 30 hours
Duration of postoperative mechanical ventilation
after postoperative admission to ICU, an expected average of 30 hours
Horovitz - indices
Time Frame: for up to 24 h after postoperative admission to ICU
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
Time Frame: during treatment at the intensive care unit, for an average of 3 weeks
Incidence of acute renal failure
during treatment at the intensive care unit, for an average of 3 weeks
Duration of hospitalisation
Time Frame: From admission to ICU and up to discharge from the hospital, an expected average of 10 days
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
Time Frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
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
Time Frame: for up to 24 h after postoperative admission to ICU
Number of patients with thromboembolic or allergic adverse events.
for up to 24 h after postoperative admission to ICU
Ventilator - associated pneumonia
Time Frame: after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days
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
Time Frame: after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days
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
Time Frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
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
Time Frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
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
Time Frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
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
Time Frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
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
Time Frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Amount of infused fibrinogen concentrate
During the period between inclusion into the study and 24 h after postoperative admission to ICU

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preoperative antiaggregatory medication
Time Frame: at the day before surgery
number of patients with preoperative intake of any antiaggregatory medication. kind of antiaggregatory medication.
at the day before surgery
infused crystalloid and colloid volume
Time Frame: intraoperatively and for up to 24 h after 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
Time Frame: at the day before surgery
age of the patient
at the day before surgery
euroSCORE
Time Frame: at the day before surgery
perioperative risk assessment
at the day before surgery
Weight
Time Frame: at the day before surgery
Weight of the patient
at the day before surgery
Height
Time Frame: at the day before surgery
height of the patient
at the day before surgery
ASA score
Time Frame: at the day before surgery
Preoperatively assessed anesthesia risk score
at the day before surgery
clamping time
Time Frame: intraoperatively
Duration of intraoperative clamping of the aorta
intraoperatively
CPB time
Time Frame: intraoperatively
Duration of extracorporeal circulation intraoperatively
intraoperatively
Priming volume
Time Frame: intraoperatively
Volume of the priming volume of the extracorporeal circulation
intraoperatively
INR
Time Frame: preoperatively and up to 24 h after admission to ICU
International Normalized Ratio
preoperatively and up to 24 h after admission to ICU
aPTT
Time Frame: preoperatively and up to 24 h after admission to ICU
activated partial prothrombin time [sec]
preoperatively and up to 24 h after admission to ICU
Platelet count
Time Frame: preoperatively and up to 24 h after admission to ICU
platelet count
preoperatively and up to 24 h after admission to ICU
CT
Time Frame: Intraoperatively and up to 24 h after admission to ICU
Clotting time in the EXTEM and INTEM test of the Rotem device
Intraoperatively and up to 24 h after admission to ICU
MCF
Time Frame: intraoperatively and up to 24h after admission to ICU
Maximal clot firmness in the EXTEM- and INTEM test of the ROTEM device
intraoperatively and up to 24h after admission to ICU
AUC
Time Frame: intraoperatively and up to 24h after admission to ICU
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Goethe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 343/12

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