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

Bone Marrow Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846352
• Other study ID #: IRB00007668
• Status: Completed
• Phase: N/A
• First received: February 2, 2009
• Last updated: April 18, 2017
• Start date: January 2009
• Est. completion date: August 2, 2010

Study information

• Verified date: August 2009
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2, 2010
• Est. primary completion date: August 2, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Transplantation

Intervention

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).

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	The University of Mississippi Medical Center	Jackson	Mississippi
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Ohio State University, University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Krowka MJ, Rosenow EC 3rd, Hoagland HC. Pulmonary complications of bone marrow transplantation. Chest. 1985 Feb;87(2):237-46. Review. — View Citation

Rañó A, Agustí C, Jimenez P, Angrill J, Benito N, Danés C, González 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. — View Citation

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. — View Citation

White P, Bonacum JT, Miller CB. Utility of fiberoptic bronchoscopy in bone marrow transplant patients. Bone Marrow Transplant. 1997 Oct;20(8):681-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in therapy due to results obtained from bronchoscopy.		When results of bronchoscopy are available
Secondary	In-Hospital and three month mortality		Three months from time of enrollment
Secondary	Duration of antibiotic therapy		Variable