Modified Ultrafiltration in Cardiac Surgery - Full Text View

Purpose

The purpose of this study is to find out, whether filtration of the blood in patients undergoing cardiac surgery, beneficially influences the coagulation system.

Condition	Intervention
Coagulopathy Rethoracotomy Blood Loss Transfusion Requirements	Device: modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Assessment of the Influence of Modified Ultrafiltration on Primary and Secondary Hemostasis in Cardiac Surgery Patients

Resource links provided by NLM:

MedlinePlus related topics: Bleeding Disorders Heart Surgery

U.S. FDA Resources

Further study details as provided by Goethe University:

Primary Outcome Measures:

ex vivo platelet aggregation (TRAPtest) [ Time Frame: 20 min after filtration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

secondary hemostasis assessed by ROTEM [ Time Frame: 20 min before and after filtration ] [ Designated as safety issue: No ]
blood loss [ Time Frame: 24 h after filtration ] [ Designated as safety issue: No ]
kind and number of transfused blood products [ Time Frame: 24h after filtration ] [ Designated as safety issue: No ]
conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration) [ Time Frame: 20 min before and after filtration ] [ Designated as safety issue: No ]
rate of rethoracotomy for bleeding [ Time Frame: 24h after filtration ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	June 2009
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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	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 Other Name: Maquet haemoconcentrator, BC 20 plus
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	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 Other Name: Maquet haemoconcentrator, BC 20 plus

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

electice cardiac surgery patients undergoing complex procedures: CABG and valve double-valve aortic surgery Re-Dos

Criteria

Inclusion Criteria:

patients undergoing complex cardiac surgery procedures

Exclusion Criteria:

none

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998647

Locations

Germany
Goethe University hospital, Clinic for Anaesthesioloy
Frankfurt am Main, Germany, 60590

Sponsors and Collaborators

Goethe University

Investigators

Principal Investigator:

Christian F Weber, Dr.

Goethe University Frankfurt, Clinic for Anaesthesiology, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Weber CF, Jámbor 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. Epub 2010 Dec 3.

Responsible Party:	Christian Weber / Dr. med., Clinic for Anaesthesiology, Johann Wolfgang Goethe University Frankfurt
ClinicalTrials.gov Identifier:	NCT00998647 History of Changes
Other Study ID Numbers:	370/08 MUF
Study First Received:	October 19, 2009
Last Updated:	April 22, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Goethe University:

modified ultrafiltration
cardiac surgery
ROTEM
Multiple Electrode Aggregometry

Additional relevant MeSH terms:

Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhage
Hematologic Diseases

Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013