Modified Ultrafiltration in Cardiac Surgery

Completed

• Conditions: Transfusion Requirements; Coagulopathy; Rethoracotomy; Blood Loss
• Interventions: Device: modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus

• 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.

Study Timeline

• Study Start: 2009-06
• Status Verified: 2009-10
• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-10-19
• Study First Posted: 2009-10-20
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Last Update Submitted: 2010-04-22
• Last Update Posted: 2010-04-23

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

Arm && Interventions

Group	Intervention	Description
with modified ultrafiltration	modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus	elective cardiac surgery patients undergoing complex surgical intervention: coronary artery bypass grafting AND valve surgery double valve surgery aortic surgery Re-Dos
without modified ultrafiltration	modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus	elective cardiac surgery patients undergoing complex surgical intervention: coronary artery bypass grafting AND valve surgery double valve surgery aortic surgery Re-Dos

Primary Outcome Measures

Name	Time	Method
ex vivo platelet aggregation (TRAPtest)	20 min after filtration

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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