Modified Ultrafiltration in Cardiac Surgery

NCT ID: NCT00998647

Last Updated: 2010-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Coagulopathy Rethoracotomy Blood Loss Transfusion Requirements

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus

Intervention Type DEVICE

usage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids

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

modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus

Intervention Type DEVICE

usage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Maquet haemoconcentrator, BC 20 plus

Eligibility Criteria

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Inclusion Criteria

* patients undergoing complex cardiac surgery procedures

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goethe University

OTHER

Sponsor Role lead

Responsible Party

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Clinic for Anaesthesiology, Johann Wolfgang Goethe University Frankfurt

Principal Investigators

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Christian F Weber, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Goethe University hospital, Clinic for Anaesthesioloy

Frankfurt am Main, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 17046273 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21130474 (View on PubMed)

Other Identifiers

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370/08 MUF

Identifier Type: -

Identifier Source: org_study_id

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