Pulmonary Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation

Post Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

Pulmonary Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420172
• Other study ID #: 2011H0214
• Status: Completed
• Phase: N/A
• First received: August 16, 2011
• Last updated: February 24, 2017
• Start date: August 2011
• Est. completion date: July 8, 2016

Study information

• Verified date: October 2015
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This will be a retrospective study and analysis of subjects who have undergone a hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC at any time between 01Jan2000 and 30Jun2011.

This study will determine factors influencing pulmonary disease and associated treatment strategies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 8, 2016
• Est. primary completion date: July 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients who have undergone a hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC at any time between 01Jan2000 and 30Jun2011.

• Age > 18 years

Exclusion Criteria:

• Age <18 years

• Prisoners

Related Conditions & MeSH terms

• Lung Diseases
• Post Hematopoietic Stem Cell Transplantation

Intervention

Other:
• Data Collection
Collection of data on patients who were seen at OSUMC at any time between 01Jan2000 and 30Jun2011 post hematopoietic stem cell transplantation

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Karen Wood

Country where clinical trial is conducted

United States, 

References & Publications (5)

Afessa B, Litzow MR, Tefferi A. Bronchiolitis obliterans and other late onset non-infectious pulmonary complications in hematopoietic stem cell transplantation. Bone Marrow Transplant. 2001 Sep;28(5):425-34. Review. — View Citation

Dudek AZ, Mahaseth H, DeFor TE, Weisdorf DJ. Bronchiolitis obliterans in chronic graft-versus-host disease: analysis of risk factors and treatment outcomes. Biol Blood Marrow Transplant. 2003 Oct;9(10):657-66. — View Citation

Verleden GM, Vanaudenaerde BM, Dupont LJ, Van Raemdonck DE. Azithromycin reduces airway neutrophilia and interleukin-8 in patients with bronchiolitis obliterans syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):566-70. — View Citation

Vos R, Vanaudenaerde BM, Verleden SE, De Vleeschauwer SI, Willems-Widyastuti A, Van Raemdonck DE, Schoonis A, Nawrot TS, Dupont LJ, Verleden GM. A randomised controlled trial of azithromycin to prevent chronic rejection after lung transplantation. Eur Respir J. 2011 Jan;37(1):164-72. doi: 10.1183/09031936.00068310. — View Citation

Williams KM, Chien JW, Gladwin MT, Pavletic SZ. Bronchiolitis obliterans after allogeneic hematopoietic stem cell transplantation. JAMA. 2009 Jul 15;302(3):306-14. doi: 10.1001/jama.2009.1018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A retrospective diagnostic review on pulmonary disease related to hematopoietic stem cell transplantation.	To determine factors influencing pulmonary disease related to HSCT.	Up to 15 years
Secondary	A retrospective treatment review on treatment strategies for pulmonary disease related to hematopoietic stem cell transplantation.	To review treatment strategies for pulmonary disease post transplant for effectiveness.	Up to 15 years