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

NCT ID: NCT01826123

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2019-05-31

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.

Conditions

Coagulopathy During Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Conventional laboratory testing (Central laboratory)

Intervention Type: DEVICE

aPTT, INR, fibrinogen concentration, platelet count

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.

Group Type: ACTIVE_COMPARATOR

POC testing

Intervention Type: DEVICE

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)

Interventions

Conventional laboratory testing (Central laboratory)

aPTT, INR, fibrinogen concentration, platelet count

Intervention Type: 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)

Intervention Type: DEVICE

Other Intervention Names

viscoleastic measures using the ROTEM(R) device and; aggregometric measures using the Multiplate(R) device

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Goethe University

OTHER

Sponsor Role: lead

Responsible Party

Christian F. Weber, MD

Dr. med. Dr. med. habil. Christian Friedrich Weber

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian F Weber, MD

Role: STUDY_DIRECTOR

Goethe University

Kai Zacharowski, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Alexander Schellhaaß, MD

Role: STUDY_CHAIR

Heidelberg University

Stefan Hofer, PhD, MD

Role: STUDY_CHAIR

Heidelberg University

Roland Freynschlag, MD

Role: STUDY_CHAIR

University of Linz

Hans Gombotz, PhD, MD

Role: STUDY_CHAIR

University of Linz

Jan Roesner, MD

Role: STUDY_CHAIR

University of Rostock

Locations

University of Linz

Linz, Upper Austria, Austria

University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Goethe - University

Frankfurt am Main, Hesse, Germany

University of Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Countries

Austria; Germany

References

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.

Reference Type: BACKGROUND

PMID: 22914710 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22685493 (View on PubMed)

Other Identifiers

343/12

Identifier Type: -

Identifier Source: org_study_id