The Pulmonary Protection Trial
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|ClinicalTrials.gov Identifier: NCT01614951|
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : April 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Lung Disease||Procedure: Perfusion of the lungs Drug: HTK Custodiol Other: Standard ECC||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pulmonary Dysfunction After Open Heart Surgery: Randomized Clinical Trial With Focus on Lung-protective Interventions|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
|Experimental: Pulmonary perfusion||
Procedure: Perfusion of the lungs
Pulmonary perfusion with oxygenated blood during ECC.
Drug: HTK Custodiol
Pulmoplegia before ECC.
Other: Standard ECC
ECC after standard procedure
- Oxygenation Index [ Time Frame: From pre operation until 24 hours post operation ]To investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation index after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).
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): NCT01614951
|Copenhagen N, Denmark, 2200|
|Principal Investigator:||Daniel A. Steinbrüchel, prof.||Rigshospitalet, Thoracic Surgery|