NCT00854165

Brief Summary

Survival after cadaveric lung transplantation in recipients depended on ventilation support prior to transplantation has been reported to have relative high surgical mortality and morbidity rate. The objectives of this study were to describe the short-term outcomes of bilateral sequential lung transplantation under extracorporeal membrane oxygenation (ECMO) support in a consecutive series of patients who depended on noninvasive and invasive ventilation support preoperatively .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 3, 2009

Status Verified

March 1, 2009

Enrollment Period

2 months

First QC Date

March 1, 2009

Last Update Submit

March 2, 2009

Conditions

Respiratory Failure

Keywords

lung transplantationrespiratory failureECMOLung transplants in respiratory failure patients

Outcome Measures

Primary Outcomes (1)

  • 6 months and one year survival after lung transplatn.

    6 months and one year posttransplant

Secondary Outcomes (1)

  • Pulmonary function results, at baseline and posttransplant 1, 3, and 6 months.

    baseline, post-op 1,3, and 6 months

Eligibility Criteria

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

Between July 2006 and July 2008, we performed bilateral sequential lung transplantation under venoarterious ECMO support in 10 respiratory failure patients with various lung diseases. This study wanted to report the preoperative condition, postoperative complications, and short-term outcome after lung transplantation.

You may qualify if:

  • respiratory patients depended on ventilator supports prior to lung transplant

You may not qualify if:

  • non-cardaveric lung transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Yung-Chie Lee, MD, PhD

    Department of Surgery, National Taiwan University Hospital

    STUDY DIRECTOR

  • Hsao-Hsun Hsu, MD

    Department of Surgery, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2009

First Posted

March 3, 2009

Study Start

February 1, 2009

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

March 3, 2009

Record last verified: 2009-03

Locations

TW(1)