Clinical trial NCT01826123: Point-of-Care Testing in Coagulopathic Patients Undergoing Cardiac Surgery - a Multicenter Study
Official title: Point-of-Care Testing - A Prospective, Randomized, Controlled Multicenter Study of Efficacy in Coagulopathic Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coagulopathy During Cardiac Surgery
Keywords: Coagulopathy
Hemorrhage
Cardiac surgery
Point-of-Care testing
POC
ROTEM
multiplate
Multiple electrode aggregometry (MEA)
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: packed red blood cell concentrate (PRBC) transfusion rate
timeFrame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Secondary outcomes:
measure: Transfusion rate of Fresh Frozen Plasma
timeFrame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
measure: Postoperative Blood loss
timeFrame: for up to 24 h after postoperative admission to ICU
measure: Duration of mechanical ventilation
timeFrame: after postoperative admission to ICU, an expected average of 30 hours
measure: Horovitz - indices
timeFrame: for up to 24 h after postoperative admission to ICU
measure: Incidence of acute renal failure
timeFrame: during treatment at the intensive care unit, for an average of 3 weeks
measure: Duration of hospitalisation
timeFrame: From admission to ICU and up to discharge from the hospital, an expected average of 10 days
measure: rethoracotomies
timeFrame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
measure: Thromboembolic or allergic adverse events
timeFrame: for up to 24 h after postoperative admission to ICU
measure: Ventilator - associated pneumonia
timeFrame: after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days
measure: Postoperative Sepsis
timeFrame: after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days
measure: Transfusion rate of platelet concentrates
timeFrame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
measure: Age of each platelet concentrate
timeFrame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
measure: Amount of infused PCC
timeFrame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
measure: Amount of infused rVIIa
timeFrame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
measure: Amount of infused fibrinogen concentrate
timeFrame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Other outcomes:
measure: Preoperative antiaggregatory medication
timeFrame: at the day before surgery
measure: infused crystalloid and colloid volume
timeFrame: intraoperatively and for up to 24 h after admission to ICU
measure: Age
timeFrame: at the day before surgery
measure: euroSCORE
timeFrame: at the day before surgery
measure: Weight
timeFrame: at the day before surgery
measure: Height
timeFrame: at the day before surgery
measure: ASA score
timeFrame: at the day before surgery
measure: clamping time
timeFrame: intraoperatively
measure: CPB time
timeFrame: intraoperatively
measure: Priming volume
timeFrame: intraoperatively
measure: INR
timeFrame: preoperatively and up to 24 h after admission to ICU
measure: aPTT
timeFrame: preoperatively and up to 24 h after admission to ICU
measure: Platelet count
timeFrame: preoperatively and up to 24 h after admission to ICU
measure: CT
timeFrame: Intraoperatively and up to 24 h after admission to ICU
measure: MCF
timeFrame: intraoperatively and up to 24h after admission to ICU
measure: AUC
timeFrame: intraoperatively and up to 24h after admission to ICU
Locations:
city: Linz
country: Austria
facility: University of Linz
state: Oberösterreich
city: Heidelberg
country: Germany
facility: University of Heidelberg
state: Baden Württemberg
city: Frankfurt
country: Germany
facility: Goethe - University
state: Hessen
city: Rostock
country: Germany
facility: University of Rostock
state: Mecklenburg Vorpommern
Study officials:
affiliation: Goethe University
name: Christian F Weber, MD
role: STUDY_DIRECTOR
affiliation: Goethe University
name: Kai Zacharowski, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heidelberg University
name: Alexander Schellhaaß, MD
role: STUDY_CHAIR
affiliation: Heidelberg University
name: Stefan Hofer, PhD, MD
role: STUDY_CHAIR
affiliation: University of Linz
name: Roland Freynschlag, MD
role: STUDY_CHAIR
affiliation: University of Linz
name: Hans Gombotz, PhD, MD
role: STUDY_CHAIR
affiliation: University of Rostock
name: Jan Roesner, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.