Modified Ultrafiltration in Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coagulopathy, Rethoracotomy, Blood Loss, Transfusion Requirements

Intervention / Treatment
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* Device: modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing complex cardiac surgery procedures Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with modified ultrafiltration<br>elective cardiac surgery patients undergoing complex surgical intervention: coronary artery bypass grafting AND valve surgery double valve surgery aortic surgery Re-Dos | Device: modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus<br>* usage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids<br>* Other names: Maquet haemoconcentrator, BC 20 plus;|
| without modified ultrafiltration<br>elective cardiac surgery patients undergoing complex surgical intervention: coronary artery bypass grafting AND valve surgery double valve surgery aortic surgery Re-Dos | Device: modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus<br>* usage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids<br>* Other names: Maquet haemoconcentrator, BC 20 plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ex vivo platelet aggregation (TRAPtest) |  | 20 min after filtration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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modified ultrafiltration, cardiac surgery, ROTEM, Multiple Electrode Aggregometry