Recruiting NCT07374874
A Cohort Study on the Association Between the ANS Function and Acute GvHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Transplant-Related Disorder. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Cohort Study on the Association Between the Autonomic Nervous System Function and Acute GvHD After Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation
Overview
This is a prospective observational study. The investigators plan to utilize this model as a tool for early classification and interrogate ANS function of transplant recipients.
Primary outcome measures
- Result of heart rate response to standing test [Time frame: Within one month before the transplantation and during 17-25 days after the transplantation.]
- Result of piloerection test [Time frame: Within one month before the transplantation and during 17-25 days after the transplantation.]
- Number of participants with abnormal dynamic electrocardiography readings [Time frame: Within one month before the transplantation and during 17-25 days after the transplantation.]
Secondary outcome measures (1)
- Incidence of severe acute GvHD after transplantation within 100 days and incidences of acute GvHD (any grade) in various target organs. [Time frame: 100 days after transplantation]
Eligibility criteria
Inclusion criteria
- Patients must be > 16 years of age;
- Patients receiving HLA-haploidentical transplants;
- Patients have to sign an informed consent form before the start of the research procedure.
Exclusion criteria
- Tandem transplantation or multiple transplantations;
- Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
- Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Institute of Hematology & Blood Diseases Hospital — Tianjin
Identifiers
NCT: NCT07374874 · IIT2025112