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TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients

NCT04098445 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2025-07-15

No results posted yet for this study

Summary

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.

Conditions

  • Hematopoietic Stem Cell Transplant (HSCT)
  • Diffuse Alveolar Hemorrhage
  • Thrombotic Microangiopathies
  • Interstitial Pneumonitis
  • Bronchiolitis Obliterans

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Stella Davies, MBBS, PhD, MRCP · Children's Hospital Medical Center, Cincinnati

Eligibility

Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-08
Primary Completion
2026-09-30
Completion
2036-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04098445 on ClinicalTrials.gov