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Lung Perfusion With Oxygenated Blood During Aortic Clamping (PulPer-001-Sch)

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.
ClinicalTrials.gov Identifier: NCT01186510
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Pulmonary dysfunction presumably linked to an inflammatory response is frequent after cardiac operations using cardiopulmonary bypass (CPB) and pulmonary hypoperfusion.

Aim of the study: To evaluate the protective effect of continuous pulmonary perfusion with oxygenated blood during aortic crossclamping on the inflammatory response.


Condition or disease Intervention/treatment
Postoperative Pulmonary Dysfunction Procedure: lung perfusion Procedure: no lung perfusion

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lung Perfusion With Oxygenated Blood During Aortic Clamping
Study Start Date : August 2010
Primary Completion Date : November 2012
Study Completion Date : November 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: Lung perfusion Procedure: lung perfusion
see literature of proceeding
Active Comparator: no lung perfusion Procedure: no lung perfusion
see literature of proceeding


Outcome Measures

Primary Outcome Measures :
  1. Inflammatory marker [ Time Frame: 5 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80 ys
  • Cardiopulmonary bypass procedure
  • FEV1 <80%
  • COPD >II

Exclusion Criteria:

  • Emergency cases
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): NCT01186510


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arndt-H. Kiessling, Head Cardiovascular Research, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01186510     History of Changes
Other Study ID Numbers: PulPer-001-Sch
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013