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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Wake Forest Baptist Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ohio State University
University of Mississippi Medical Center
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT00846352
First received: February 2, 2009
Last updated: August 5, 2009
Last verified: August 2009
  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 Phase
Bone Marrow Transplantation
Procedure: Variation in the time for performing bronchoscopy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Baptist Health:

Primary Outcome Measures:
  • Change in therapy due to results obtained from bronchoscopy. [ Time Frame: When results of bronchoscopy are available ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In-Hospital and three month mortality [ Time Frame: Three months from time of enrollment ] [ Designated as safety issue: No ]
  • Duration of antibiotic therapy [ Time Frame: Variable ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846352

Contacts
Contact: Ali S Wahla, M.D 336-716-3182 awahla@wfubmc.edu
Contact: John F Conforti, D.O 336-716-4649 jconfort@wfubmc.edu

Locations
United States, Mississippi
The University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Mark R Bowling, M.D    601-815-2005    mbowling@medicine.umsmed.edu   
Principal Investigator: Mark R Bowling, M.D         
United States, North Carolina
Wake Forest University Baptist Medical Center Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Ali S Wahla, M.D    336-716-3182    awahla@wfubmc.edu   
Principal Investigator: John F Conforti, D.O         
Sub-Investigator: Ali S Wahla, M.D         
Sub-Investigator: David Hurd, M.D         
Sub-Investigator: Arjun Chatterjee, M.D         
Sub-Investigator: Kirk Depriest, D.O         
Sub-Investigator: Kevin High, M.D         
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Karen Wood, M.D    614-293-4925    Karen.Wood@osumc.edu   
Sub-Investigator: Jennifer McCallister, M.D         
Sponsors and Collaborators
Wake Forest Baptist Health
Ohio State University
University of Mississippi Medical Center
Investigators
Principal Investigator: John F Conforti, D.O Wake Forest Baptist Health
  More Information

Publications:
Responsible Party: Dr. John Conforti, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT00846352     History of Changes
Other Study ID Numbers: IRB00007668
Study First Received: February 2, 2009
Last Updated: August 5, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 30, 2014