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

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Marrow Transplantation
• Intervention / Treatment: Procedure: Variation in the time for performing 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • The University of Mississippi Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Bronchoscopy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Ohio State University; University of Mississippi Medical Center
• Investigators: Principal Investigator: John F Conforti, D.O, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Kantrow SP, Hackman RC, Boeckh M, Myerson D, Crawford SW. Idiopathic pneumonia syndrome: changing spectrum of lung injury after marrow transplantation. Transplantation. 1997 Apr 27;63(8):1079-86. doi: 10.1097/00007890-199704270-00006.
• Krowka MJ, Rosenow EC 3rd, Hoagland HC. Pulmonary complications of bone marrow transplantation. Chest. 1985 Feb;87(2):237-46. doi: 10.1378/chest.87.2.237.
• Seiden MV, Elias A, Ayash L, Hunt M, Eder JP, Schnipper LE, Frei E 3rd, Antman KH. Pulmonary toxicity associated with high dose chemotherapy in the treatment of solid tumors with autologous marrow transplant: an analysis of four chemotherapy regimens. Bone Marrow Transplant. 1992 Jul;10(1):57-63.
• Rano A, Agusti C, Jimenez P, Angrill J, Benito N, Danes C, Gonzalez J, Rovira M, Pumarola T, Moreno A, Torres A. Pulmonary infiltrates in non-HIV immunocompromised patients: a diagnostic approach using non-invasive and bronchoscopic procedures. Thorax. 2001 May;56(5):379-87. doi: 10.1136/thorax.56.5.379.
• White P, Bonacum JT, Miller CB. Utility of fiberoptic bronchoscopy in bone marrow transplant patients. Bone Marrow Transplant. 1997 Oct;20(8):681-7. doi: 10.1038/sj.bmt.1700957.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): August 2, 2010
• Study Completion (Actual): August 2, 2010

Study Registration Dates

• First Submitted: February 2, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 18, 2009

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Bronchoscopy; Bone Marrow Transplantation; Hematopoietic Stem Cell Transplantation
• Other Study ID Numbers: IRB00007668

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No