A Prospective Study of Patients With Isolated Thrombocytopenia Following Hematopoietic Stem Cell Transplantation

Status: Completed
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Isolated thrombocytopenia is a common and severe complication of HSCT, which often leads to an increased risk of life-threatening hemorrhage, frequent requirement of platelet transfusions and extended hospital stays, representing a challenging clinical problem. Current treatments for thrombocytopenia after HSCT are frequently unsatisfactory in platelet recovery and for preventing potentially fatal bleeding complications. Therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT. Previous studies have demonstrated that decitabine, a hypomethylating agent, may reduce platelet transfusions in myelodysplastic syndrome (MDS) patients. The investigators conducted an prospective clinical trial to evaluate the safety and efficiency of rhTPO and decitabine in the treatment of thrombocytopenia following HSCT.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Platelet count ≤ 30 × 109/L persistently at day 60 post-HSCT or later;

• Neutrophil and hemoglobin were well recovered;

• Full donor chimerism was achieved;

• No response to conventional treatments (e.g. thrombopoietin, immunoglobulin, glucocorticoid alone or in combination) for a duration of at least 4 weeks;

Locations
Other Locations
China
The First affiliated Hospital of SooChow University
Suzhou
Time Frame
Start Date: 2015-10
Completion Date: 2019-04-12
Participants
Target number of participants: 97
Treatments
Experimental: Experimental Group 1
Decitabine in combination with rhTPO.
Experimental: Experimental Group 2
Decitabine
Active_comparator: Control Group
Conventional treatment except decitabine.
Sponsors
Collaborators: Peking University People's Hospital, Qilu Hospital of Shandong University, Wuhan Union Hospital, China, Nanfang Hospital, Southern Medical University, Ruijin Hospital, Fujian Medical University Union Hospital, Hebei Yanda Ludaopei Hospital, Children's Hospital of Soochow University
Leads: The First Affiliated Hospital of Soochow University

This content was sourced from clinicaltrials.gov

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