The Change of Coagulation Markers in Children With β-thalassemia Disease After Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Level of protein C,S and AT, TAT, P1+2 and D-dimer
研究概览
简要总结
Hypercoagulable state is well recognized in patients with β-thalassemia. Evidences of hypercoagulability include abnormal expression of phosphatidylserine on red blood cell (rbc) surface and consequent increased platelet activation and thrombin generation. In addition, a reduction of anticoagulants i.e. proteins C and S and antithrombin (AT) was demonstrated. However, coagulable state in patients with β-thalassemia following stem cell transplantation (SCT) has not been characterized.
详细描述
Hypercoagulable state is well recognized in patients with β-thalassemia. Evidences of hypercoagulability include abnormal expression of phosphatidylserine on red blood cell (rbc) surface and consequent increased platelet activation and thrombin generation. In addition, a reduction of anticoagulants i.e. proteins C and S and antithrombin (AT) was demonstrated. However, coagulable state in patients with β-thalassemia following stem cell transplantation (SCT) has not been characterized.Therefore, the objective is to compare coagulation markers and anticoagulants among β-thalassemics with and without SCT and normal control (NC).The subjects will be classified into 3 groups; β-thalassemia post SCT (Thal-SCT), β-thalassemia treated with regular transfusion (Thal-RT) and NC. Blood samples will be tested for annexin V (an index of abnormal expression of phosphatidylserine on rbc surface), markers of activation of coagulation system (thrombin antithrombin complex (TAT), prothrombin fragment (F1+2), and D-dimer) and anticoagulants (proteins C and S and AT).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: beta thalassemia major or beta thalassemia / Hb E who receive regular transfusion therapy (Thal- RT). The baseline Hct was more than 24% for at least 6 months.
- •Group 2: beta thalassemia major or beta thalassemia / Hb E post SCT (Thal-SCT) who were discontinued immunosuppressive drugs.
- •Group 3: Normal children (NC) who had normal Hb/Hct and MCV for age
排除标准
- •Children with beta thalassemia major or beta thalassemia / Hb E who have co-diseases such as immune hemolytic anemia, infection, or inflammatory diseases
结局指标
主要结局
Level of protein C,S and AT, TAT, P1+2 and D-dimer
时间窗: 3 years
次要结局
未报告次要终点
研究者
Nongnuch Sirachainan
Associate Prof
Mahidol University