Lung TransplantationNCT02265835

Anastomotic Airway Complications After Lung Transplantation

An observational study of Lung Transplantation and Bronchoscopy, run by KU Leuven.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Retrospective analysis of data concerning anastomotic airway complications after lung transplantation. Read more about this study

Who is it for?: Any age
Conditions the study is for: Lung Transplantation, Bronchoscopy
How many people: 432 participants
Where: No sites listed yet
Study dates: Jan 2014to Oct 2014
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Lung transplant recipients between 1/2005 en 12/2012

Who may be able to join

Lung transplantation

Who cannot join

heart and lung transplantation

About this study

Official title: Anastomotic Airway Complications After Lung Transplantation : Risk Factors, Treatment Modalities and Outcome : a Single Center Experience.

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

Conditions: Lung Transplantation, Bronchoscopy
Being tested: no intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

no interventionOther
no intervention

Study groups in NCT02265835
Study group	Role	What they receive
Cases of anastomotic airway complication		Cases of anastomotic airway complication Receives: Other: no intervention
Patients with normal anastomotic healing		Patients with normal anastomotic healing Receives: Other: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

presence of anastomotic airway complication
Based upon radiological and endoscopic reports the presence and severity of anastomotic airway complications will be assessed.
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Oct 2014

First posted16 Oct 2014 (estimated)
Study startJan 2014
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung TransplantationStudies of the same condition, open and under way.
More trials run by KU LeuvenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 432 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02265835
Sponsor's protocol ID: ML6736
Status last verified: Oct 2014
First submitted: 7 Oct 2014
Last updated: 16 Oct 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1
Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Lung Transplantation
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
RecruitingObservational study
Trifecta-Lung cfDNA-MMDx Study
Lung Transplantation

All Lung Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Anastomotic Airway Complications After Lung Transplantation : Risk Factors, Treatment Modalities and Outcome : a Single Center Experience.
ClinicalTrials.gov ID: NCT02265835
Acronym / sponsor ID: ML6736
Conditions: Lung Transplantation, Bronchoscopy
Study type: Observational
Recruitment status: Completed
Enrolment: 432 participants (actual)
Lead sponsor: KU LeuvenUniversity, hospital or other
Study start: Jan 2014
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 16 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Cases of anastomotic airway complication	–	Other: no interventionCases of anastomotic airway complication
Patients with normal anastomotic healing	–	Other: no interventionPatients with normal anastomotic healing

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Lung transplant recipients between 1/2005 en 12/2012

Key inclusion criteria (1 listed)

Lung transplantation

Key exclusion criteria (1 listed)

heart and lung transplantation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
no interventionno intervention	Other	Cases of anastomotic airway complication, Patients with normal anastomotic healing

Primary outcome

presence of anastomotic airway complication
Time frame: 18 months
Based upon radiological and endoscopic reports the presence and severity of anastomotic airway complications will be assessed.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.

Related trials for Lung Transplantation

RecruitingPhase 1
Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Lung Transplantation
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
RecruitingObservational study
Trifecta-Lung cfDNA-MMDx Study
Lung Transplantation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Transplantation and Bronchoscopy, run by KU Leuven.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

presence of anastomotic airway complication (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02265835.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.