NCT02265835

Brief Summary

Retrospective analysis of data concerning anastomotic airway complications after lung transplantation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

9 months

First QC Date

October 7, 2014

Last Update Submit

October 13, 2014

Conditions

Lung TransplantationBronchoscopy

Outcome Measures

Primary Outcomes (1)

  • presence of anastomotic airway complication

    Based upon radiological and endoscopic reports the presence and severity of anastomotic airway complications will be assessed.

    18 months

Study Arms (2)

Cases of anastomotic airway complication

Cases of anastomotic airway complication

Other: no intervention

Patients with normal anastomotic healing

Patients with normal anastomotic healing

Other: no intervention

Interventions

no interventionOTHER

no intervention

Cases of anastomotic airway complicationPatients with normal anastomotic healing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lung transplant recipients between 1/2005 en 12/2012

You may qualify if:

  • Lung transplantation

You may not qualify if:

  • heart and lung transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 16, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 16, 2014

Record last verified: 2014-10