Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01826123
NCT01826123
Unknown
Not Applicable

Point-of-Care Testing - A Prospective, Randomized, Controlled Multicenter Study of Efficacy in Coagulopathic Cardiac Surgery Patients

Goethe University4 sites in 2 countries160 target enrollmentStarted: July 2013Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsCoagulopathy During Cardiac Surgery

Overview

Phase
Not Applicable
Sponsor
Goethe University
Enrollment
160
Locations
4
Primary Endpoint
packed red blood cell concentrate (PRBC) transfusion rate
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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)
  • •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

Outcomes

Primary Outcomes

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 Outcomes

  • Transfusion rate of Fresh Frozen Plasma(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
  • Thromboembolic or allergic adverse events(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)
  • rethoracotomies(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
  • Postoperative Sepsis(after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days)
  • Transfusion rate of platelet concentrates(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
  • Amount of infused PCC(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
  • Horovitz - indices(for up to 24 h after postoperative admission to ICU)
  • Ventilator - associated pneumonia(after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days)
  • Age of each platelet concentrate(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
  • Amount of infused rVIIa(During the period between inclusion into the study and 24 h after postoperative admission to ICU)
  • Amount of infused fibrinogen concentrate(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)
  • Incidence of acute renal failure(during treatment at the intensive care unit, for an average of 3 weeks)
  • Duration of hospitalisation(From admission to ICU and up to discharge from the hospital, an expected average of 10 days)

Investigators

Sponsor
Goethe University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christian F. Weber, MD

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

Goethe University

Study Sites (4)

Loading locations...

Similar Trials

Completed
Not Applicable
Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental IllnessHyperlipidemiaDiabetesHypertension
NCT02029989University of Minnesota121
Not yet recruiting
Not Applicable
Effectiveness of point of care testing (POCT) devices for postpartum hemorrhage: A systematic review and meta-analysispostpartum hemorrhage
JPRN-UMIN000048272Yokohama City University
Active, not recruiting
Not Applicable
The RAPID COVID-19 TRIAGE AlgorithmCOVID-19
NCT04353154Ottawa Heart Institute Research Corporation66
Completed
Phase 2
Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic SubjectsAtopic Asthma
NCT02758548Novartis Pharmaceuticals193
Not yet recruiting
Not Applicable
Randomized Prospective Multi Center Cohort Study for Primary Diagnosis of Clinically Significant Prostate Cancer With Combination of PSA/DRE and Multi Parametric Magnetic Resonance ImagingProstate Cancer
NCT04993508Heinrich-Heine University, Duesseldorf1,908