NCT07747246

Brief Summary

This is a retrospective observational study evaluating the efficacy and safety of romiplostim for promoting platelet engraftment in patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) at Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology between January 2025 to May 2026. Medical records were reviewed to collect data on platelet recovery time, transfusion requirements, and adverse events. The primary endpoint was time to platelet engraftment. Secondary endpoints included platelet recovery kinetics, transfusion requirements, transplant-related complications, and safety outcomes.No interventions were assigned as part of this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

July 27, 2026

Last Update Submit

July 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to Platelet Recovery to ≥50×10⁹/L

    Time from allogeneic hematopoietic stem cell transplantation (Day 0) to the first date of achieving platelet count ≥50×10⁹/L without transfusion support in the preceding 7 days.

    up to Day 100

Secondary Outcomes (2)

  • Time to Platelet Engraftment

    up to Day 100

  • Time to Neutrophil Engraftment

    up to Day 60

Study Arms (2)

Romiplostim Group

Patients who received romiplostim after allogeneic hematopoietic stem cell transplantation for platelet engraftment.

Control Group

Patients who did not receive romiplostim after allogeneic hematopoietic stem 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 underwent allo-HSCT at Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology (Wuhan, China) from January 2025 to May 2026.

You may qualify if:

  • Patients diagnosed with AA, AL, MDS, PMF, or other hematologic diseases according to internationally accepted diagnostic criteria
  • Patients who underwent allo-HSCT during the study period
  • Patients with complete clinical characteristics, transplantation records, and follow-up data

You may not qualify if:

  • Primary graft failure;
  • Death before hematopoietic engraftment
  • Missing key clinical data;(4) Use of thrombopoietin receptor agonists other than romiplostim

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Officials

  • wen

    Tongji Hospital Affiliated to Tongji Medical College of Huaz- hong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Hematology

Study Record Dates

First Submitted

July 27, 2026

First Posted

August 5, 2026

Study Start

January 1, 2025

Primary Completion

May 1, 2026

Study Completion

July 15, 2026

Last Updated

August 5, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to patient privacy and institutional policy.

Locations