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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Hannover Medical School.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00940147
First received: July 14, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 180
Study Start Date: January 2007
Estimated Study Completion Date: August 2009
Estimated 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

Contacts
Contact: Thomas Fuehner, M.D. +49 511 532 ext 3505 fuehner.thomas@mh-hannover.de
Contact: Jens T Gottlieb, M.D. +49 511 532 ext 3505 gottlieb.jens@mh-hannover.de

Locations
Germany
Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: Thomas Fuehner, M.D.     +49 511 532 ext 3505     fuehner.thomas@mh-hannover.de    
Contact: Jens T Gottlieb, M.D.     +49 532 511 ext 3505     gottlieb.jens@mh-hannover.de    
Principal Investigator: Thomas Fuehner, M.D.            
Sponsors and Collaborators
Hannover Medical School
  More Information

No publications provided

Responsible Party: Thomas Fuehner, 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: July 14, 2009
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on May 19, 2013