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CompletedNCT00846352Updated Apr 20, 2017

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

An interventional study of Variation in the time for performing bronchoscopy in Bone Marrow Transplantation, sponsored by Wake Forest University Health Sciences. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-20.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Bone Marrow Transplantation

Keywords

  • Bone Marrow Transplantation
  • Hematopoietic Stem Cell Transplantation
  • Bronchoscopy
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In context

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • 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

  • Active comparator
    Late bronch

    This group will receive bronchoscopy within 5 days of enrollment.

    Procedure: Variation in the time for performing bronchoscopy

Interventions

  • ProcedureVariation 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).

    Also known as: Bronchoscopy

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What researchers measure

Primary outcomes

  1. Change in therapy due to results obtained from bronchoscopy.

    Time frame: When results of bronchoscopy are available

Secondary outcomes

  1. In-Hospital and three month mortality

    Time frame: Three months from time of enrollment

  2. Duration of antibiotic therapy

    Time frame: Variable

07

Study locations

3 sites
  • The University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • Wake Forest University Baptist Medical Center
    Winston-Salem, North Carolina 27157, United States
  • The Ohio State University Medical Center
    Columbus, Ohio 43210, United States
08

References and documents

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. PubMed 9133468 ↗
  • 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. PubMed 2981658 ↗
  • 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. PubMed 1515880 ↗
  • 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. PubMed 11312407 ↗
  • 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. PubMed 9383232 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00846352
Lead sponsor
Wake Forest University Health Sciences
Collaborators
Ohio State University, University of Mississippi Medical Center
Responsible party
Sponsor
First posted
Feb 18, 2009
Start date
Jan 2009
Primary completion
Aug 2, 2010
Completion
Aug 2, 2010
Last update
Apr 20, 2017

Study contacts

John F Conforti, D.O
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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