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Completed

NCT Number: NCT07747246

Retrospective Study of Romiplostim for Platelet Engraftment After Allo-HSCT

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430030, China

About this study

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an important curative treatment for various hematological malignancies and non-malignant hematological disorders. However, delayed platelet engraftment remains a frequent complication after transplantation and is associated with prolonged thrombocytopenia, increased bleeding risk, higher transfusion requirements, and extended hospitalization.

Romiplostim, a thrombopoietin receptor agonist (TPO-RA), promotes megakaryocyte proliferation, differentiation, and platelet production through activation of the thrombopoietin receptor (c-Mpl). Although romiplostim has been widely used in immune thrombocytopenia and chemotherapy-induced thrombocytopenia, its efficacy and safety in promoting platelet engraftment after allo-HSCT remain unclear.

The investigators retrospectively analyzed patients who underwent allo-HSCT at Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology between January 2025 to May 2026. Patients were categorized into a romiplostim group and a control group according to whether romiplostim was administered after transplantation.

To minimize baseline imbalance and potential confounding factors, propensity score matching (PSM) was performed at a 1:1 ratio.

The primary endpoint was time to platelet engraftment. Secondary endpoints included platelet recovery kinetics, transfusion requirements, transplant-related complications, and safety outcomes.

Kaplan-Meier analysis with log-rank testing and Cox proportional hazards regression models were performed to evaluate factors associated with platelet engraftment.

Inclusion criteria

  • 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

Exclusion criteria

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Time to Platelet Recovery to ≥50×10⁹/L

    Time frame: up to Day 100

    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.

Secondary outcomes

  1. Time to Platelet Engraftment

    Time frame: up to Day 100

    Time from transplantation (Day 0) to the first of 7 consecutive days with platelet count ≥20×10⁹/L without transfusion support.

  2. Time to Neutrophil Engraftment

    Time frame: up to Day 60

    Time from transplantation (Day 0) to the first of 3 consecutive days with absolute neutrophil count (ANC) ≥0.5×10⁹/L.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

Retrospective Clinical Study on the Efficacy and Safety of Romiplostim for Promoting Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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