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NCT Number: NCT07374874

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

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.

Recruiting

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Key information

Conditions

Transplant-Related Disorder

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300000, China

Location status: Recruiting

Location contact

Yahui Feng

CONTACT

[email protected]

022-23608045

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Result of heart rate response to standing test

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

    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.

  2. Result of piloerection test

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

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

  3. Number of participants with abnormal dynamic electrocardiography readings

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

    Dynamic electrocardiography will be performed 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.

    Time frame: 100 days after transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Yahui Feng

CONTACT

[email protected]

022-23608045

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

A Cohort Study on the Association Between the Autonomic Nervous System Function and Acute GvHD After Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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