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

NCT01826123 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2017-05-04

No results posted yet for this study

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.

Conditions

  • Coagulopathy During Cardiac Surgery

Interventions

DEVICE

Conventional laboratory testing (Central laboratory)

aPTT, INR, fibrinogen concentration, platelet count

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)

Sponsors & Collaborators

  • Goethe University

    lead OTHER

Principal Investigators

  • Christian F Weber, MD · Goethe University

  • Kai Zacharowski, PhD, MD · Goethe University

  • Alexander Schellhaaß, MD · Heidelberg University

  • Stefan Hofer, PhD, MD · Heidelberg University

  • Roland Freynschlag, MD · University of Linz

  • Hans Gombotz, PhD, MD · University of Linz

  • Jan Roesner, MD · University of Rostock

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01826123 on ClinicalTrials.gov