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NCT00998647 Clinical Trial

Modified Ultrafiltration in Cardiac Surgery

Blood Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00998647
Other study ID # 370/08 MUF
Secondary ID
Status Completed
Phase N/A
First received October 19, 2009
Last updated April 22, 2010
Start date June 2009
Est. completion date April 2010

Study information
Verified date October 2009
Source Goethe University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 60
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients undergoing complex cardiac surgery procedures

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus
usage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids

Locations
Country Name City State
Germany Goethe University hospital, Clinic for Anaesthesioloy Frankfurt am Main

Sponsors (1)
Lead Sponsor Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Boodhwani M, Williams K, Babaev A, Gill G, Saleem N, Rubens FD. Ultrafiltration reduces blood transfusions following cardiac surgery: A meta-analysis. Eur J Cardiothorac Surg. 2006 Dec;30(6):892-7. Epub 2006 Oct 13. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary ex vivo platelet aggregation (TRAPtest) 20 min after filtration No
Secondary secondary hemostasis assessed by ROTEM 20 min before and after filtration No
Secondary blood loss 24 h after filtration No
Secondary kind and number of transfused blood products 24h after filtration No
Secondary conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration) 20 min before and after filtration No
Secondary rate of rethoracotomy for bleeding 24h after filtration No
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