NCT00846352

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2010

Completed
Last Updated

April 20, 2017

Status Verified

August 1, 2009

Enrollment Period

1.6 years

First QC Date

February 2, 2009

Last Update Submit

April 18, 2017

Conditions

Bone Marrow Transplantation

Keywords

Bone Marrow TransplantationHematopoietic Stem Cell TransplantationBronchoscopy

Outcome Measures

Primary Outcomes (1)

  • Change in therapy due to results obtained from bronchoscopy.

    When results of bronchoscopy are available

Secondary Outcomes (2)

  • In-Hospital and three month mortality

    Three months from time of enrollment

  • Duration of antibiotic therapy

    Variable

Study Arms (2)

Early Bronch

ACTIVE COMPARATOR

This group will receive bronchoscopy within 36 hours of enrollment into the study.

Procedure: Variation in the time for performing bronchoscopy

Late bronch

ACTIVE COMPARATOR

This group will receive bronchoscopy within 5 days of enrollment.

Procedure: Variation in the time for performing bronchoscopy

Interventions

Variation in the time for performing bronchoscopyPROCEDURE

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
Early BronchLate bronch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who have had allogenic or autologous HSCT who are admitted to the BMT, and felt to need bronchoscopy by their physician.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (5)

  • 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.

    PMID: 9133468BACKGROUND

  • 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.

    PMID: 2981658BACKGROUND

  • 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.

    PMID: 1515880BACKGROUND

  • 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.

    PMID: 11312407BACKGROUND

  • 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.

    PMID: 9383232BACKGROUND

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • John F Conforti, D.O

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 18, 2009

Study Start

January 1, 2009

Primary Completion

August 2, 2010

Study Completion

August 2, 2010

Last Updated

April 20, 2017

Record last verified: 2009-08

Locations

US(3)