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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: Adult patients receiving HLA-haploidentical transplants

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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

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

Other outcomes

Sponsors and contacts

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