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Modified Ultrafiltration in Cardiac Surgery

Assessment of the Influence of Modified Ultrafiltration on Primary and Secondary Hemostasis in Cardiac Surgery Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00998647
Enrollment
60
Registered
2009-10-20
Start date
2009-06-30
Completion date
2010-04-30
Last updated
2010-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Coagulopathy, Rethoracotomy, Transfusion Requirements

Keywords

modified ultrafiltration, cardiac surgery, ROTEM, Multiple Electrode Aggregometry

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.

Interventions

DEVICEmodified ultrafiltration using Maquet haemoconcentrator, BC 20 plus

usage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids

Sponsors

Goethe University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients undergoing complex cardiac surgery procedures

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frame
ex vivo platelet aggregation (TRAPtest)20 min after filtration

Secondary

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026