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Modified Ultrafiltration in Cardiac Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00998647
First Posted: October 20, 2009
Last Update Posted: April 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Goethe University
  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:


Further study details as provided by Goethe University:

Primary Outcome Measures:
  • ex vivo platelet aggregation (TRAPtest) [ Time Frame: 20 min after filtration ]

Secondary Outcome Measures:
  • secondary hemostasis assessed by ROTEM [ Time Frame: 20 min before and after filtration ]
  • blood loss [ Time Frame: 24 h after filtration ]
  • kind and number of transfused blood products [ Time Frame: 24h after filtration ]
  • conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration) [ Time Frame: 20 min before and after filtration ]
  • rate of rethoracotomy for bleeding [ Time Frame: 24h after filtration ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: October 19, 2009
First Posted: October 20, 2009
Last Update Posted: April 23, 2010
Last Verified: October 2009

Keywords provided by Goethe University:
modified ultrafiltration
cardiac surgery
ROTEM
Multiple Electrode Aggregometry

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders