Early Endoscopic Indicators for OACs After Lung Transplantation: Development of a Novel Mucosal Healing Score

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Fuehner, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00940147
First received: July 14, 2009
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

Airway complications are a significant cause of morbidity after lung transplantation (LTx). Bronchoscopic evaluation may help to identify risk factors for requiring interventions later.


Condition
Airway Complication Which Require Any Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Indicators for Obstructive Airway Complications After Lung

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Primary endpoint of this study was any obstructive airway complication (AC) which required desobliterative intervention. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • secondary endpoint included anastomosis-related death. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: January 2007
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients with OAC, Score finding
2
patients without OAC, Score finding

Detailed Description:

The investigators evaluated lung transplant recipients prospectively. Adult patients surviving 90 day after LTx will be included. The investigators propose a classification of airway healing based on the endoscopic bronchial appearances at days 7, 14, 21, 90, 180 and 365 after LTx. A score system including mucosal healing, full tissue necrosis (=dehiscence), lose sutures, fibrin plugs, polyps and malacia will be developed (max. score 8 points/date). Endoscopic findings will be correlated with the development of obstructive airway complications (OAC, requiring >1 intervention). Afterwards the new score system will be applied prospectively in the patients.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

LTx 01.2007-05.2009

Criteria

Inclusion Criteria:

  • 3 month survivor after LTx
  • no OAC

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940147

Locations
Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Thomas Fuehner
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Fuehner, Principal Investigator, Hannover Medical School
ClinicalTrials.gov Identifier: NCT00940147     History of Changes
Other Study ID Numbers: 2008_01, OAC_1.0
Study First Received: July 14, 2009
Last Updated: June 5, 2013
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on April 15, 2014