Completed

NCT Number: NCT00940147

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

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

Completed

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Key information

Conditions

Airway Complication Which Require Any Intervention

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School

Hanover, 30625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

3 month survivor after LTx
no OAC

Exclusion criteria

Treatment and study plan

Primary outcomes

Primary endpoint of this study was any obstructive airway complication (AC) which required desobliterative intervention.

Time frame: 1 year

Secondary outcomes

secondary endpoint included anastomosis-related death.

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Thomas Fuehner

Other

Registry information

Official study title

Early Indicators for Obstructive Airway Complications After Lung

Acronym: OAC

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jul 15, 2009
Registry last updated: Jun 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.