Cardiac Surgery, Coagulation Management
Conditions
Keywords
POC, ROTEM, Multiplate, bleeding tendency, coagulation management, amount of transfused red blood cell concentrates,, FFP, platelet concentrates, rate of rethoracotomy, ventilation time
Brief summary
The purpose of the study is to determine the efficacy of two different algorithms for coagulation management in patients undergoing cardiac surgery suffering from increased bleeding tendency. Algorithm 1 is based on conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration,...) and Algorithm 2 is based on thrombelastometry using the ROTEM-device and impedance aggregometry using the Multiplate device.
Interventions
PROCEDUREPoint-of-Care versus conventional coagulation management
Patients are randomized to receive either point-of-care based or conventional coagulation measurements based coagulation therapy in the case of increased perioperative bleeding tendency
Sponsors
University Hospital, Essen
Goethe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 18 years, combined surgical procedures (ACB & valve surgery), double valve surgery, aortic surgery, Re-Dos
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| amount of transfused red blood cell concentrates | 24 h after begin of surgical intervention |
Secondary
| Measure | Time frame |
|---|---|
| other transfused blood products including FFP, platelet concentrates and coagulation factor concentrates | 24h after surgical intervention |
| rate of rethoracotomy for bleeding | 24h after surgical intervention |
| ventilation time on ICU | till discharge from ICU |
Countries
Germany
Outcome results
None listed