Assessment of the Influence of Modified Ultrafiltration on Primary and Secondary Hemostasis in Cardiac Surgery Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- ex vivo platelet aggregation (TRAPtest)
Study Overview
Brief Summary
The purpose of this study is to find out, whether filtration of the blood in patients undergoing cardiac surgery, beneficially influences the coagulation system.
Detailed Description
The impact of modified ultrafiltration following extracorporeal circulation on primary and secondary hemostasis is controversial. In this study we intend to assess both, primary and secondary hemostasis prior to and after the usage of modified ultrafiltration. Primary hemostasis is assessed using Multiple Electrode Aggregometry (Multiplate) and secondary hemostasis is assessed performing thrombelastometry using the ROTEM device. Patients are preoperatively randomized to receive either modified ultrafiltration or no filtration.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients undergoing complex cardiac surgery procedures
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
ex vivo platelet aggregation (TRAPtest)
Time Frame: 20 min after filtration
Secondary Outcomes
- secondary hemostasis assessed by ROTEM(20 min before and after filtration)
- blood loss(24 h after filtration)
- kind and number of transfused blood products(24h after filtration)
- conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration)(20 min before and after filtration)
- rate of rethoracotomy for bleeding(24h after filtration)