Thrombocytopenia
Conditions
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.
Detailed description
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
Interventions
None listed
Sponsors
Tongji Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Platelet Recovery to ≥50×10⁹/L | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Platelet Engraftment | 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. |
| Time to Neutrophil Engraftment | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORwen
Tongji Hospital Affiliated to Tongji Medical College of Huaz- hong University of Science and Technology
Outcome results
None listed