An observational study in Hematopoietic Stem Cell Transplant (HSCT), Diffuse Alveolar Hemorrhage and Thrombotic Microangiopathies, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 9 sites in United States. Open to participants aged Up to 24 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited.
This is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (alloHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.
52 studies on the registry are indexed under Thrombotic Microangiopathies; 21 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 175 across 20 observational studies indexed under Thrombotic Microangiopathies.
Browse Thrombotic Microangiopathies studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
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The study participants will include eligible patients undergoing allogeneic or autologous HSCT at participating institutions.
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Exclusion Criteria:
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Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prospective multi-institutional cohort study in pediatric patients undergoing allogeneic (alloHSCT) or autologous hematopoietic stem cell transplantation (autoHSCT).
Incidence of Lung Injury after HSCT
Participants will be assessed for lung injury at 24 months after HSCT
Time frame: 24 months after HSCT
Started Sep 2021 (actual). Primary completion is estimated for Sep 2033, 144 months after the start.
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Thrombotic Microangiopathies →
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