Linking autonomic nervous system function to acute graft-versus-host disease
A Cohort Study on the Association Between the Autonomic Nervous System Function and Acute GvHD After Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation
This study tests whether monitoring autonomic nervous system (ANS) function can help detect acute graft-versus-host disease early in patients receiving HLA-haploidentical transplants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT07374874 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort of HLA-haploidentical hematopoietic transplant recipients aged over 16. Researchers will monitor autonomic nervous system (ANS) function around the transplant period using physiological measurements and apply a predictive model to classify risk of acute graft-versus-host disease (aGvHD). No interventional treatments are assigned; clinical care follows standard practice while data are collected. The aim is to determine whether changes in ANS signals precede or correlate with aGvHD onset and could support earlier detection.
Who should consider this trial
Good fit: Ideal candidates are patients older than 16 receiving HLA-haploidentical hematopoietic transplants who can give informed consent and comply with monitoring procedures.
Not a fit: Patients undergoing tandem or multiple transplants, those with mental or medical conditions preventing compliance, or those judged to be at high risk from participation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could allow earlier detection of aGvHD through ANS monitoring, enabling quicker treatment and potentially reducing complications.
How similar studies have performed: Some preliminary work has linked ANS measures (for example heart rate variability) to immune and transplant outcomes, but using ANS function specifically to predict aGvHD remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients must be \> 16 years of age; 2. Patients receiving HLA-haploidentical transplants; 3. Patients have to sign an informed consent form before the start of the research procedure. Exclusion Criteria: 1. Tandem transplantation or multiple transplantations; 2. Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements; 3. Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.
Where this trial is running
Tianjin, Tianjin Municipality
- Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yahui Feng
- Email: fengyahui@ihcams.ac.cn
- Phone: 022-23608045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.