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Comparison of Two Different Heart-lung Machine Filling Methods: Precoating Versus Colloidal Fluids

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247051
First Posted: November 24, 2010
Last Update Posted: August 29, 2011
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 (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
  Purpose

The study is a single-center, randomized, un-blinded treatment study in which patients (>78 years) with the use off a heart-lung machine were provided into two study arms.

Patient wit "precoating" have a filling of the machine with their own blood. In the comparator arm, a standard priming is used.


Condition Intervention
Priming Cardiac Surgery Cardio Pulmonary Bypass Procedure: Precoating Procedure: Standard priming

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • blood loss [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Inflammatory response [ Time Frame: one week ]

Estimated Enrollment: 90
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Precoating Procedure: Precoating
preoperative filling of heart lung machine with patients blood
Active Comparator: Standard priming Procedure: Standard priming
preoperative filling of heart lung machine with colloids

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   78 Years to 95 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 78 years
  • CPB

Exclusion Criteria:

  • Hb <12 mg/dl
  • Off pump surgery
  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): NCT01247051


Locations
Germany
Goethe University
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
  More Information

Responsible Party: Arndt-H. Kiessling, Head cardiovascular research, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01247051     History of Changes
Other Study ID Numbers: PRE001AHK
First Submitted: November 23, 2010
First Posted: November 24, 2010
Last Update Posted: August 29, 2011
Last Verified: August 2011

Keywords provided by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals:
priming
cardiac surgery
cardio pulmonary bypass
precoating