Pulmonary Complications of Allografts

Completed

• Conditions: Pulmonary Complications

• Registration Number: NCT01219972
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

This is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells.

Detailed Description

* Objectives To estimate the incidence of late (at least occurring 100 days after transplantation) pulmonary complications following allogeneic blood stem cells transplantation

* Study Design Prospective Cohort Study All follow-up data were actualiized in September, 2016.

* Sample Size 200 transplanted patients

* Main Endpoint Non infectious pulmonary complications within the first 3 years

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2009-02
• Study First Submitted: 2010-10-11
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

• Allogeneic Blood stem cell transplantation
• Alive at day 100 post-transplant

Exclusion Criteria

• Non informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Non infectious pulmonary complication	3 years

Secondary Outcome Measures

Name	Time	Method
Survival after non infectious pulmonary complication	3 years and 10 years
Overall survival	3 years and 10 years
Long term time course of Pulmonary Function Tests (PFTs)	3 years and 10 years

Trial Locations

Locations (1)

Hôpital Saint Louis; 🇫🇷 Paris, France