NCT07328724

Brief 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. The clinical characteristics, laboratory profiles, managements, and clinical outcomes will be prospectively collected.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
130mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jan 2026Dec 2036

First Submitted

Initial submission to the registry

December 27, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2036

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2036

Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

10.5 years

First QC Date

December 27, 2025

Last Update Submit

December 27, 2025

Conditions

Keywords

hematopoietic cell transplantationcritical illnessmanagementprognosistransplant complication

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival after admission to the intensive care unit.

    Before ICU discharge; within 6 months after ICU discharge; and within 1 year after ICU discharge.

Secondary Outcomes (6)

  • Non-relapse mortality

    Before ICU discharge; within 6 months after ICU discharge; and within 1 year after ICU discharge.

  • Relapse

    At ICU admission and within 1 year of ICU discharge.

  • Transplant complication

    At ICU admission and within 1 year of ICU discharge.

  • Organ failure

    At ICU admission and within 1 year of ICU discharge.

  • Organ support therapy

    At ICU admission and within 1 year after ICU discharge.

  • +1 more secondary outcomes

Study Arms (1)

Critically ill patients after hematopoietic cell transplantation

Patients who are admitted to the intensive care unit after undergoing hematopoietic cell transplantation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are admitted to ICU after undergoing hematopoietic cell transplantation at any of the participating medical centers.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Peking University People's Hospital

Beijing, China

Location

Xinqiao hospital of the third military medical university

Chongqing, China

Location

First Affiliated Hospital of Zhejiang University

Hangzhou, China

Location

First Affiliated Hospital of Harbin Medical University

Harbin, China

Location

Hematology Hospital of Chinese Academy of Medical Sciences

Tianjin, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Xiao Hui Zhang, MD

CONTACT

Peng Zhao, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 27, 2025

First Posted

January 9, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 30, 2036

Study Completion (Estimated)

December 31, 2036

Last Updated

January 9, 2026

Record last verified: 2025-12

Locations