An observational study in Thrombocytopenia, sponsored by Tongji Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Tongji Hospital · Observational
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.
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:
Exclusion Criteria:
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's enrollment of 103 is below the median of 120 across 183 observational studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients who received romiplostim after allogeneic hematopoietic stem cell transplantation for platelet engraftment.
Patients who did not receive romiplostim after allogeneic hematopoietic stem cell transplantation.
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.
Time frame: up to Day 100
Time to Platelet Engraftment
Time from transplantation (Day 0) to the first of 7 consecutive days with platelet count ≥20×10⁹/L without transfusion support.
Time frame: up to Day 100
Time to Neutrophil Engraftment
Time from transplantation (Day 0) to the first of 3 consecutive days with absolute neutrophil count (ANC) ≥0.5×10⁹/L.
Time frame: up to Day 60
Plan to share: No — Individual participant data will not be shared due to patient privacy and institutional policy.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Tongji Hospital