Clinical trial NCT00998647: Modified Ultrafiltration in Cardiac Surgery
Official title: Assessment of the Influence of Modified Ultrafiltration on Primary and Secondary Hemostasis in Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulopathy
Rethoracotomy
Blood Loss
Transfusion Requirements
Keywords: modified ultrafiltration
cardiac surgery
ROTEM
Multiple Electrode Aggregometry
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2009-10-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: electice cardiac surgery patients undergoing complex procedures: CABG and valve double-valve aortic surgery Re-Dos

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.

Eligibility criteria: Inclusion Criteria:

* patients undergoing complex cardiac surgery procedures

Exclusion Criteria:

* none

Primary outcomes:
measure: ex vivo platelet aggregation (TRAPtest)
timeFrame: 20 min after filtration
Secondary outcomes:
measure: secondary hemostasis assessed by ROTEM
timeFrame: 20 min before and after filtration
measure: blood loss
timeFrame: 24 h after filtration
measure: kind and number of transfused blood products
timeFrame: 24h after filtration
measure: conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration)
timeFrame: 20 min before and after filtration
measure: rate of rethoracotomy for bleeding
timeFrame: 24h after filtration
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Goethe University hospital, Clinic for Anaesthesioloy
Study officials:
affiliation: Goethe University Frankfurt, Clinic for Anaesthesiology, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany
name: Christian F Weber, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.ejcts.2006.09.014. Epub 2006 Oct 13.
citation: Weber CF, Jambor C, Strasser C, Moritz A, Papadopoulos N, Zacharowski K, Meininger D. Normovolemic modified ultrafiltration is associated with better preserved platelet function and less postoperative blood loss in patients undergoing complex cardiac surgery: a randomized and controlled study. J Thorac Cardiovasc Surg. 2011 May;141(5):1298-304. doi: 10.1016/j.jtcvs.2010.09.057. Epub 2010 Dec 3.