Critical IllnessCARE-HCTNCT07328724
Critical Illness After Hematopoietic Cell Transplantation
An observational study of Critical Illness and Ventilated Patients, run by Peking University People's Hospital at 6 sites in China.
Trial summary
This is a prospective, multicenter observational trial for patients who develop critical illness after hematopoietic cell transplantation. Patients who are admitted to the intensive care unit after undergoing hematopoietic cell transplantation at the participating medical centers will be enrolled in this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness, Ventilated Patients, Hematopoetic Stem Cell Transplantation
- How many people
- 4,000 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jan 2026to 31 Dec 2036
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are admitted to ICU after undergoing hematopoietic cell transplantation at any of the participating medical centers.
Who may be able to join
- Patients who underwent hematopoietic cell transplantation at any of the participating medical centers.
- Patients who are admitted to ICU for the management of critical illness following hematopoietic cell transplantation.
Who cannot join
- Admitted to ICU for a reason other than critical illness (e.g., routine postoperative monitoring) and discharged within 2 days of ICU admission.
- Unavailable in-ICU clinical outcomes or absent key baseline characteristics.
- Any other conditions that, in the opinion of the investigator, can interfere with the interpretation of data.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Peking University People's Hospital
Beijing
Zhi Xue Li, MD, 861088324577, lzx2010301121@stu.pku.edu.cn
Xinqiao hospital of the third military medical university
Chongqing
Xi Zhang, MD, 861088324577, zhangxxi@sina.com
First Affiliated Hospital of Zhejiang University
Hangzhou
Yi Luo, MD, 861088324577, luoyijr@zju.edu.cn
First Affiliated Hospital of Harbin Medical University
Harbin
Sheng Jing Fan, MD, 861088324577, fansjhmu@163.com
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin
Er Lie Jiang, 861088324577, jiangerlie@ihcams.ac.cn
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Ling Hui Xia, MD, 861088324577, linghuixia@hust.edu.cn
About this study
Official title: Critical Illness Among Recipients of Hematopoietic Cell Transplantation (CARE-HCT): a Prospective, Multicenter Observational Study in China
This is a prospective, multicenter observational trial for patients who develop critical illness after hematopoietic cell transplantation. Patients who are admitted to the intensive care unit after undergoing hematopoietic cell transplantation at the participating medical centers will be enrolled in this study. The clinical characteristics, laboratory profiles, managements, and clinical outcomes will be prospectively collected.
- Conditions
- Critical Illness, Ventilated Patients, Hematopoetic Stem Cell Transplantation, Transplant Complication
- Keywords
- hematopoietic cell transplantation, critical illness, management, prognosis, transplant complication
- Medical subject headings
- Critical Illness
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 |
|---|---|---|
| Critically ill patients after hematopoietic cell transplantation | Patients who are admitted to the intensive care unit after undergoing hematopoietic cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival after admission to the intensive care unit.
Measured: Before ICU discharge; within 6 months after ICU discharge; and within 1 year after ICU discharge.
Secondary outcomes (6)
Non-relapse mortality
Non-relapse mortality after ICU admission.
Measured: Before ICU discharge; within 6 months after ICU discharge; and within 1 year after ICU discharge.
Relapse
Disease relapse or progression at or after ICU admission.
Measured: At ICU admission and within 1 year of ICU discharge.
Transplant complication
Hematopoietic-cell-transplantation-associated complications at or after ICU admission.
Measured: At ICU admission and within 1 year of ICU discharge.
Organ failure
Organ failure occurring at or after ICU admission.
Measured: At ICU admission and within 1 year of ICU discharge.
Organ support therapy
The use of organ support therapy at or after ICU admission.
Measured: At ICU admission and within 1 year after ICU discharge.
Long-term survival data
Overall survival, non-relapse mortality, and transplant-related mortality during long-term follow-up after ICU discharge.
Measured: Up to 5 years after ICU discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2036 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Xinqiao hospital of the third military medical university, First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Harbin Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328724
- Sponsor's protocol ID
- 2025-z259
- Acronym
- CARE-HCT
- Status last verified
- Dec 2025
- First submitted
- 27 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Illness Among Recipients of Hematopoietic Cell Transplantation (CARE-HCT): a Prospective, Multicenter Observational Study in China
- ClinicalTrials.gov ID
- NCT07328724
- Acronym / sponsor ID
- CARE-HCT / 2025-z259
- Conditions
- Critical Illness, Ventilated Patients, Hematopoetic Stem Cell Transplantation, Transplant Complication
- Keywords
- hematopoietic cell transplantation, critical illness, management, prognosis, transplant complication
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Xinqiao hospital of the third military medical university, First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Harbin Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2036 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 9 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, multicenter observational trial for patients who develop critical illness after hematopoietic cell transplantation. Patients who are admitted to the intensive care unit after undergoing hematopoietic cell transplantation at the participating medical centers will be enrolled in this study. The clinical characteristics, laboratory profiles, managements, and clinical outcomes will be prospectively collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients after hematopoietic cell transplantation | – | –Patients who are admitted to the intensive care unit after undergoing hematopoietic cell transplantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are admitted to ICU after undergoing hematopoietic cell transplantation at any of the participating medical centers.
Key inclusion criteria (2 listed)
- Patients who underwent hematopoietic cell transplantation at any of the participating medical centers.
- Patients who are admitted to ICU for the management of critical illness following hematopoietic cell transplantation.
Key exclusion criteria (3 listed)
- Admitted to ICU for a reason other than critical illness (e.g., routine postoperative monitoring) and discharged within 2 days of ICU admission.
- Unavailable in-ICU clinical outcomes or absent key baseline characteristics.
- Any other conditions that, in the opinion of the investigator, can interfere with the interpretation of data.
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
Overall survival
Time frame: Before ICU discharge; within 6 months after ICU discharge; and within 1 year after ICU discharge.
Overall survival after admission to the intensive care unit.
6 secondary outcomes
Non-relapse mortality
Time frame: Before ICU discharge; within 6 months after ICU discharge; and within 1 year after ICU discharge.
Relapse
Time frame: At ICU admission and within 1 year of ICU discharge.
Transplant complication
Time frame: At ICU admission and within 1 year of ICU discharge.
Organ failure
Time frame: At ICU admission and within 1 year of ICU discharge.
Organ support therapy
Time frame: At ICU admission and within 1 year after ICU discharge.
Long-term survival data
Time frame: Up to 5 years after ICU discharge.
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 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Ventilated Patients, run by Peking University People's Hospital at 6 sites 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 2 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: opening soon, as of the sponsor's last update on 9 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 6 sites 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 Xiao Hui Zhang, MD (861088324577, zhangxh@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Before ICU discharge; within 6 months after ICU discharge; and within 1 year after ICU discharge.). 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 9 Jan 2026.