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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 24
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.

Disqualifiers

Subjects over 24 years of age.

Trial population

The study participants will include eligible patients undergoing allogeneic or autologous HSCT at participating institutions.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: Pediatric and young adult HSCT recipients

Trial outcomes

Primary outcomes

1

Incidence of Lung Injury after HSCT

Participants will be assessed for lung injury at 24 months after HSCT

Time frame
24 months after HSCT

Secondary outcomes

Other outcomes

Sponsors and contacts

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