The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT

Study Overview
=================
Brief Summary
-----------------
This study evaluates the addition of Eltrombopag after Hematopoietic stem cell transplantation (HSCT) to improve the engraftment of hematopoietic stem cell. Half of the participants will receive Eltrombopag,while the other will not receive the Eltrombopag.

Detailed Description
-----------------
With the progress of transplantation technology，allogeneic hematopoietic stem cell transplantation is becoming an important treatment for hematological diseases and the long-term survival of patients is gradually improved. However, thrombocytopenia after transplantation has always been an important complication. Studies have shown that about 20% patients had different degrees of thrombocytopenia. Eltrombopag could promote hematopoietic stem cell proliferation and differentiation in vitro studies. It has also been widely used in the treatment of immune thrombocytopenia (ITP) and aplastic anemia(AA) and increased platelet levels in such diseases. Eltrombopag is also used to treat poor platelet engraftment after transplantation and the effective rate is about 60%-80%. Therefore, the application of Eltrombopag at early time after transplantation might promote platelet engraftment and reduce platelet transfusions.

Official Title
-----------------
The Prospective Randomized Controlled Clinical Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Allogeneic Hematopoietic Stem Cell Transplantation, Eltrombopag

Intervention / Treatment
-----------------
* Drug: Eltrombopag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with definite diagnosis of hematological diseases, more than 30 kg, age18-60 years, gender and race are not limited; Acceptance of allogeneic hematopoietic stem cell transplantation; Voluntary acceptance of the study Exclusion Criteria: Patients with severe organ dysfunction or disease； Patients who cannot tolerate oral Eltrombopag therapy; Patients who refuse all-HSCT and Eltrombopag treatment; Patients that investigator believed not suitable for enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment Group<br>The patients will receive Eltrombopag treatment after transplantation at d1. | Drug: Eltrombopag<br>* The patients will receive Eltrombopag treatment after transplantation<br>|
| Control Group<br>The patients will not receive Eltrombopag treatment after transplantation. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The engraftment of platelet | the day of platelet engraftment | 3 years | 
| The levels of platelet | The levels of platelet at 30 days after transplantation | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of platelet transfusions | The number of platelet units be transfused to the patients before platelet engraftment | 3 years |