The Pulmonary Protection Trial

NCT01614951 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2014-04-25

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01614951 on ClinicalTrials.gov