Transplant-Related DisorderNCT07374874
A Cohort Study on the Association Between the ANS Function and Acute GvHD
An observational study of Transplant-Related Disorder, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Transplant-Related Disorder
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients receiving HLA-haploidentical transplants at the Institute of Hematology, Chinese Academy of Medical Sciences (IHCAMS)
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300000
Yahui Feng, 022-23608045, fengyahui@ihcams.ac.cn
About this study
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
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients receiving HLA-haploidentical transplants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 100 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start18 Dec 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant-Related DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374874
- Sponsor's protocol ID
- IIT2025112
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07374874
- Acronym / sponsor ID
- IIT2025112
- Conditions
- Transplant-Related Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients receiving HLA-haploidentical transplants | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients receiving HLA-haploidentical transplants at the Institute of Hematology, Chinese Academy of Medical Sciences (IHCAMS)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant-Related Disorder, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yahui Feng (022-23608045, fengyahui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result of heart rate response to standing test (time frame: Within one month before the transplantation and during 17-25 days after the transplantation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.