Stem Cell Transplant Complications Clinical Trial
Official title:
Role of Fiberoptic Bronchoscopy in Hematopoietic Stem Cell Transplant Patients With Pulmonary Infiltrates in Changing Management Decisions: An Observational Study
NCT number | NCT04998903 |
Other study ID # | 2141128 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2016 |
Est. completion date | February 27, 2020 |
Verified date | February 2024 |
Source | King Faisal Specialist Hospital and Research Centre Madinah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Hematopoietic stem cell transplant (HSCT) is a modality that is increasingly utilized to treat various haematological disorders with a varying degree of success. From 2006 to 2019 use of HSCT worldwide has increased from 50,417 to an estimated 1.5 million. Disease relapse, graft versus host disease (GVHD) and infections are the leading causes of morbidity and mortality in patients with HSCT. Pulmonary complications, in particular, are common in patients with HSCT, and the diagnostic approach and management of these complications remain a challenge. FOB is one of the standard and least invasive diagnostic modality for these patients. However, the diagnostic yield and change in clinical decision making in those studies have been variable. Furthermore, all these studies were retrospective, with one exception. The investigators designed an observational study to understand the rate of change in clinical decision making following Fiberoptic bronchoscopy (FOB). The investigators also looked at the yield of FOB and characteristics associated with a positive diagnostic yield.
Status | Completed |
Enrollment | 51 |
Est. completion date | February 27, 2020 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: - All patients who suffered from GVHD following Hematopoietic Stem Cell Transplant and had Pulmonary Infiltrate's requiring Fiberoptic Bronchoscopy. Exclusion Criteria: - Any patients aged less than 14 years. - Unable to consent - Those patients who the primary physician decided not have Fiberoptic Bronchoscopy. |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Faisal Specialist Hospital and Research Centre | Riyadh |
Lead Sponsor | Collaborator |
---|---|
King Faisal Specialist Hospital and Research Centre Madinah |
Saudi Arabia,
Gratwohl A, Pasquini MC, Aljurf M, Atsuta Y, Baldomero H, Foeken L, Gratwohl M, Bouzas LF, Confer D, Frauendorfer K, Gluckman E, Greinix H, Horowitz M, Iida M, Lipton J, Madrigal A, Mohty M, Noel L, Novitzky N, Nunez J, Oudshoorn M, Passweg J, van Rood J, — View Citation
Harris B, Geyer AI. Diagnostic Evaluation of Pulmonary Abnormalities in Patients with Hematologic Malignancies and Hematopoietic Cell Transplantation. Clin Chest Med. 2017 Jun;38(2):317-331. doi: 10.1016/j.ccm.2016.12.008. — View Citation
Lim DH, Lee J, Lee HG, Park BB, Peck KR, Oh WS, Ji SH, Lee SH, Park JO, Kim K, Kim WS, Jung CW, Park YS, Im YH, Kang WK, Park K. Pulmonary complications after hematopoietic stem cell transplantation. J Korean Med Sci. 2006 Jun;21(3):406-11. doi: 10.3346/j — View Citation
Lucena CM, Torres A, Rovira M, Marcos MA, de la Bellacasa JP, Sanchez M, Domingo R, Gabarrus A, Mensa J, Agusti C. Pulmonary complications in hematopoietic SCT: a prospective study. Bone Marrow Transplant. 2014 Oct;49(10):1293-9. doi: 10.1038/bmt.2014.151 — View Citation
Styczynski J, Tridello G, Koster L, Iacobelli S, van Biezen A, van der Werf S, Mikulska M, Gil L, Cordonnier C, Ljungman P, Averbuch D, Cesaro S, de la Camara R, Baldomero H, Bader P, Basak G, Bonini C, Duarte R, Dufour C, Kuball J, Lankester A, Montoto S — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of change in clinical decision making following FOB | number of patients whose clinical management changed directly as a consequence of fiberoptic bronchoscopy | within 1 months of FOB | |
Secondary | Clinical characteristics associated with a positive yield in Fiberoptic Bronchoscopy | clinical characteristics associated with a positive microbiology, virology or cytological yield. | Within 2 weeks of presentation to FOB | |
Secondary | CT scan patterns associated with a positive yield in Fiberoptic Bronchoscopy | clinical characteristics associated with a positive microbiology, virology or cytological yield. | CT within one month before the FOB | |
Secondary | Six month outcome of patients following FOB | Mortality in the six months following FOB. | six months |
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