The Pulmonary Protection Trial
NCT01614951 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2014-04-25
Summary
The purpose of this study is to investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation capacity after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).
Conditions
- Chronic Obstructive Lung Disease
Interventions
- 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
Sponsors & Collaborators
-
Lundbeck Foundation
collaborator OTHER -
Rigshospitalet, Denmark
lead OTHER
Principal Investigators
-
Daniel A. Steinbrüchel, prof. · Rigshospitalet, Thoracic Surgery
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2013-11-30
- Completion
- 2013-11-30
Countries
- Denmark
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