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Modified Ultrafiltration in Cardiac Surgery

Completed
Conditions
Transfusion Requirements
Coagulopathy
Rethoracotomy
Blood Loss
Registration Number
NCT00998647
Lead Sponsor
Goethe University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • patients undergoing complex cardiac surgery procedures
Exclusion Criteria
  • none

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ex vivo platelet aggregation (TRAPtest)20 min after filtration
Secondary Outcome Measures
NameTimeMethod
secondary hemostasis assessed by ROTEM20 min before and after filtration
blood loss24 h after filtration
kind and number of transfused blood products24h after filtration
conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration)20 min before and after filtration
rate of rethoracotomy for bleeding24h after filtration

Trial Locations

Locations (1)

Goethe University hospital, Clinic for Anaesthesioloy

🇩🇪

Frankfurt am Main, Germany

Goethe University hospital, Clinic for Anaesthesioloy
🇩🇪Frankfurt am Main, Germany

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