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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846352
First Posted: February 18, 2009
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ohio State University
University of Mississippi Medical Center
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
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.

Condition Intervention
Bone Marrow Transplantation Procedure: Variation in the time for performing bronchoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Trial Comparing Early Versus Late Bronchoscopy in Hematopoietic Stem Cell Transplant Patients With Pulmonary Infiltrates.

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Change in therapy due to results obtained from bronchoscopy. [ Time Frame: When results of bronchoscopy are available ]

Secondary Outcome Measures:
  • In-Hospital and three month mortality [ Time Frame: Three months from time of enrollment ]
  • Duration of antibiotic therapy [ Time Frame: Variable ]

Enrollment: 22
Actual Study Start Date: January 2009
Study Completion Date: August 2, 2010
Primary Completion Date: August 2, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early Bronch
This group will receive bronchoscopy within 36 hours of enrollment into the study.
Procedure: Variation in the time for performing bronchoscopy
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).
Other Name: Bronchoscopy
Active Comparator: Late bronch
This group will receive bronchoscopy within 5 days of enrollment.
Procedure: Variation in the time for performing bronchoscopy
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).
Other Name: Bronchoscopy

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846352


Locations
United States, Mississippi
The University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Wake Forest University Health Sciences
Ohio State University
University of Mississippi Medical Center
Investigators
Principal Investigator: John F Conforti, D.O Wake Forest University Health Sciences
  More Information

Publications:
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00846352     History of Changes
Other Study ID Numbers: IRB00007668
First Submitted: February 2, 2009
First Posted: February 18, 2009
Last Update Posted: April 20, 2017
Last Verified: August 2009

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Bone Marrow Transplantation
Hematopoietic Stem Cell Transplantation
Bronchoscopy