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

NCT01826123 | Unknown DMC

• 1 other identifier: 343/12
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 4

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

Keywords

Coagulopathy; Hemorrhage; Cardiac surgery; Point-of-Care testing; POC; ROTEM; multiplate; Multiple electrode aggregometry (MEA)

Outcome Measures

Primary Outcomes (1)

• 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.

  During the period between inclusion into the study and 24 h after postoperative admission to ICU

Secondary Outcomes (15)

• Transfusion rate of Fresh Frozen Plasma

  During the period between inclusion into the study and 24 h after postoperative admission to ICU

• Postoperative Blood loss

  for up to 24 h after postoperative admission to ICU

• Duration of mechanical ventilation

  after postoperative admission to ICU, an expected average of 30 hours

• Horovitz - indices

  for up to 24 h after postoperative admission to ICU

• Incidence of acute renal failure

  during treatment at the intensive care unit, for an average of 3 weeks

Other Outcomes (16)

• Preoperative antiaggregatory medication

  at the day before surgery

• infused crystalloid and colloid volume

  intraoperatively and for up to 24 h after admission to ICU

• Age

  at the day before surgery

Study Arms (2)

Conventional laboratory testing

ACTIVE COMPARATOR

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)

POC testing (ROTEM and Multiplate)

ACTIVE COMPARATOR

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

Interventions

Conventional laboratory testing (Central laboratory) DEVICE

aPTT, INR, fibrinogen concentration, platelet count

Conventional laboratory testing

POC testing 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)

Also known as: viscoleastic measures using the ROTEM(R) device and, aggregometric measures using the Multiplate(R) device

POC testing (ROTEM and Multiplate)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Goethe University: lead

Study Sites (4)

University of Linz

Linz, Upper Austria, 4010, Austria

Location

University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Goethe - University

Frankfurt am Main, Hesse, 60590, Germany

Location

University of Rostock

Rostock, Mecklenburg-Vorpommern, 18051, Germany

Location

Related Publications (2)

• 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.

  PMID: 22914710 BACKGROUND

• 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.

  PMID: 22685493 BACKGROUND

MeSH Terms

Conditions

Hemostatic Disorders; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian F Weber, MD

  Goethe University

  STUDY DIRECTOR

• Kai Zacharowski, PhD, MD

  Goethe University

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Dr. med. habil. Christian Friedrich Weber

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: April 8, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

AU (1); DE (3)