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Trial record 47 of 642 for:    test AND point-of-care

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

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ClinicalTrials.gov Identifier: NCT01826123
Recruitment Status : Unknown
Verified May 2017 by Christian F. Weber, MD, Goethe University.
Recruitment status was:  Active, not recruiting
First Posted : April 8, 2013
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Christian F. Weber, MD, Goethe University

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.

Condition or disease Intervention/treatment Phase
Coagulopathy During Cardiac Surgery Device: Conventional laboratory testing (Central laboratory) Device: POC testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Point-of-Care Testing - A Prospective, Randomized, Controlled Multicenter Study of Efficacy in Coagulopathic Cardiac Surgery Patients
Study Start Date : July 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. Duration of mechanical ventilation [ Time Frame: after postoperative admission to ICU, an expected average of 30 hours ]
    Duration of postoperative mechanical ventilation

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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)

  14. 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)

  15. 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


Other Outcome Measures:
  1. Preoperative antiaggregatory medication [ Time Frame: at the day before surgery ]
    number of patients with preoperative intake of any antiaggregatory medication. kind of antiaggregatory medication.

  2. 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.

  3. Age [ Time Frame: at the day before surgery ]
    age of the patient

  4. euroSCORE [ Time Frame: at the day before surgery ]
    perioperative risk assessment

  5. Weight [ Time Frame: at the day before surgery ]
    Weight of the patient

  6. Height [ Time Frame: at the day before surgery ]
    height of the patient

  7. ASA score [ Time Frame: at the day before surgery ]
    Preoperatively assessed anesthesia risk score

  8. clamping time [ Time Frame: intraoperatively ]
    Duration of intraoperative clamping of the aorta

  9. CPB time [ Time Frame: intraoperatively ]
    Duration of extracorporeal circulation intraoperatively

  10. Priming volume [ Time Frame: intraoperatively ]
    Volume of the priming volume of the extracorporeal circulation

  11. INR [ Time Frame: preoperatively and up to 24 h after admission to ICU ]
    International Normalized Ratio

  12. aPTT [ Time Frame: preoperatively and up to 24 h after admission to ICU ]
    activated partial prothrombin time [sec]

  13. Platelet count [ Time Frame: preoperatively and up to 24 h after admission to ICU ]
    platelet count

  14. 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

  15. 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

  16. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826123


Locations
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Austria
University of Linz
Linz, Oberösterreich, Austria, 4010
Germany
University of Heidelberg
Heidelberg, Baden Württemberg, Germany, 69120
Goethe - University
Frankfurt, Hessen, Germany, 60590
University of Rostock
Rostock, Mecklenburg Vorpommern, Germany, 18051
Sponsors and Collaborators
Goethe University
Investigators
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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:
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Responsible Party: Christian F. Weber, MD, Dr. med. Dr. med. habil. Christian Friedrich Weber, Goethe University
ClinicalTrials.gov Identifier: NCT01826123     History of Changes
Other Study ID Numbers: 343/12
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by Christian F. Weber, MD, Goethe University:
Coagulopathy
Hemorrhage
Cardiac surgery
Point-of-Care testing
POC
ROTEM
multiplate
Multiple electrode aggregometry (MEA)

Additional relevant MeSH terms:
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Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders