Early Versus Late Bronchoscopy in Bone Marrow Transplantation (BMT) Patients

Study Overview
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Brief Summary
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This study will evaluate the outcomes of bronchoscopy in Bome Marrow Transplant (BMT) patients who develop lung infiltrates suspicious for infections of the lungs. It will consist of two groups, one group will receive bronchoscopy within thirty six hours of enrollment, while the other group will receive bronchoscopy five days after enrollment. The purpose of this study is to determine the ideal time for bronchoscopy in this group of patients.

Detailed Description
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At this time there exist no studies that help Pulmonologists and Oncologists decide on the best time to perform diagnostic bronchoscopies in Bone Marrow Transplant patients with suspected pulmonary infections. Practice patterns vary from institution to institution and also vary widely within an institution based on the practice preferences of the attending physicians. This study is a prospective randomized trial comparing early ( within 24-36 hours of enrollment) to late ( day 5-6 after enrollment) bronchoscopy in Bone Marrow Transplant patients who develop pulmonary infiltrates or clinical evidence of respiratory infection. If patients in the late arm require earlier bronchoscopy or do not require bronchoscopy on day 5-6 then the care will be dictated by the attending physician. Only bronchoscopies that are clinically indicated will be performed. The aim is to determine the optimal timing for performing bronchoscopy in this group of patients. The primary outcomes will be change of therapy as determined by addition or removal of antibiotics, antifungals, antivirals or steroids etc. as well as the oncologist's opinion on the impact the bronchoscopic results had on care of the patient. Patients will be followed throughout their hospitalization as well as receive a phone call 3 months after hospital discharge. Written consent will be obtained from the patients or health care power of attorney in relevant cases. It is our hope that the results of this study will help better define the role of bronchoscopy in the management of Bone Marrow Transplant patients.

Official Title
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Randomized Trial Comparing Early Versus Late Bronchoscopy in Hematopoietic Stem Cell Transplant Patients With Pulmonary Infiltrates.

Conditions
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Bone Marrow Transplantation

Intervention / Treatment
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* Procedure: Variation in the time for performing bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who have had allogenic or autologous HSCT who are admitted to the BMT, and felt to need bronchoscopy by their physician. Exclusion Criteria: Active hemoptysis, allergies to topical and IV anesthetics with no appropriate substitutes available. Being on non-invasive positive pressure ventilation that would not allow for safe bronchoscopy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Bronch<br>This group will receive bronchoscopy within 36 hours of enrollment into the study. | Procedure: Variation in the time for performing bronchoscopy<br>* The study will compare outcomes amongst patients assigned to receive early bronchoscopy (within 36 hours of enrollment)versus those in whom bronchoscopy is delayed (5 days after enrollment).<br>* Other names: Bronchoscopy;|
| Active Comparator: Late bronch<br>This group will receive bronchoscopy within 5 days of enrollment. | Procedure: Variation in the time for performing bronchoscopy<br>* The study will compare outcomes amongst patients assigned to receive early bronchoscopy (within 36 hours of enrollment)versus those in whom bronchoscopy is delayed (5 days after enrollment).<br>* Other names: Bronchoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in therapy due to results obtained from bronchoscopy. |  | When results of bronchoscopy are available | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-Hospital and three month mortality |  | Three months from time of enrollment | 
| Duration of antibiotic therapy |  | Variable | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Marrow Transplantation, Hematopoietic Stem Cell Transplantation, Bronchoscopy