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

Institute of Hematology & Blood Diseases Hospital, China60 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Transplant-Related Disorder

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

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

Central Contacts

Yahui Feng

CONTACT

022-23608045 fengyahui@ihcams.ac.cn

Data from ClinicalTrials.gov

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