Modified Ultrafiltration in Cardiac Surgery
Assessment of the Influence of Modified Ultrafiltration on Primary and Secondary Hemostasis in Cardiac Surgery Patients
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 19, 2009
CompletedFirst Posted
Study publicly available on registry
October 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedApril 23, 2010
October 1, 2009
10 months
October 19, 2009
April 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ex vivo platelet aggregation (TRAPtest)
20 min after filtration
Secondary Outcomes (5)
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
Study Arms (2)
with modified ultrafiltration
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
elective cardiac surgery patients undergoing complex surgical intervention: coronary artery bypass grafting AND valve surgery double valve surgery aortic surgery Re-Dos
Interventions
usage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids
Eligibility Criteria
electice cardiac surgery patients undergoing complex procedures: CABG and valve double-valve aortic surgery Re-Dos
You may qualify if:
- patients undergoing complex cardiac surgery procedures
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Goethe University hospital, Clinic for Anaesthesioloy
Frankfurt am Main, 60590, Germany
Related Publications (2)
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.
PMID: 17046273BACKGROUNDWeber 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.
PMID: 21130474DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian F Weber, Dr.
Goethe University Frankfurt, Clinic for Anaesthesiology, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 19, 2009
First Posted
October 20, 2009
Study Start
June 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
April 23, 2010
Record last verified: 2009-10