A Cohort Study on the Association Between the ANS Function and Acute GvHD

NCT07374874 | Recruiting

• 1 other identifier: IIT2025112
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transplant-Related Disorder

Outcome Measures

Primary Outcomes (3)

• Result of heart rate response to standing test

  Autonomic nervous system functional tests including heart rate response to standing will be performed within one month before the transplantation and during 17-25 days after the transplantation.

  Within one month before the transplantation and during 17-25 days after the transplantation.

• Result of piloerection test

  Autonomic nervous system functional tests including piloerection will be performed within one month before the transplantation and during 17-25 days after the transplantation.

  Within one month before the transplantation and during 17-25 days after the transplantation.

• Number of participants with abnormal dynamic electrocardiography readings

  Dynamic electrocardiography will be performed within one month before the transplantation and during 17-25 days after the transplantation.

  Within one month before the transplantation and during 17-25 days after the transplantation.

Secondary Outcomes (1)

• Incidence of severe acute GvHD after transplantation within 100 days and incidences of acute GvHD (any grade) in various target organs.

  100 days after transplantation

Study Arms (1)

Adult patients receiving HLA-haploidentical transplants

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients receiving HLA-haploidentical transplants at the Institute of Hematology, Chinese Academy of Medical Sciences (IHCAMS)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Central Study Contacts

Yahui Feng

CONTACT

022-23608045; fengyahui@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: January 29, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-12

Locations

CN (1)