跳至主要内容
临床试验/NCT02281240
NCT02281240Unknown不适用

Pathogenesis, Diagnosis, Management and Outcome of Hemostatic Complications in Hematopoietic Stem Cell Transplantation: A Prospective Study

The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
The incidence of hemostatic complications in patients following HSCT.

研究概览

简要总结

Hemostatic disorders are common and potentially fatal complications in patients undergoing hematopoietic stem-cell transplantation (HSCT). Limited data exist on early diagnosis and prevention of these complications. The investigators undertook this prospective study to determine the incidence, predictor factors, specific pathogenesis, management and survival specially for patients with thrombotic and bleeding complication to better improve outcomes.

详细描述

Hematopoietic stem cell transplantation(HSCT)is a curative treatment for a variety of malignant and refractory benign hematologic disease, but is associated with life-threatening complications in the same time, among them, hemostatic disorders are not uncommon and presenting an increasing morbidity and mortality in HSCT recipients. Bleeding and thrombosis, two of controversial disorders, have been posing a great threat to patients in the setting of transplantation, and early hemorrhagic complication after HCST is more frequent and subject to more concern by clinical physicians, previous studies have shown the risk of bleeding in HSCT recipients is more than 10-fold higher than neoplastic patients receiving chemotherapy. Meanwhile, thrombosis events, which is characterized by hepatic veno-occlusive diseases (HVOD), transplantation related thrombotic microangiopathy (TA-TMA), and venous thromboembolism (VTE) can not be imprudently ignored with its fatal threat to patients.

Over the last two decades, it has been recognized that the relatively increasing incidence of bleeding and thrombotic complications correlating to the prognosis and quality of life for HSCT recipients. Previous studies have shown that conventional risk factors including graft-versus-host disease (GVHD), infection, thrombocytopenia, the anticoagulation therapy, damage of endothelial cell and conditioning regimen can contribute to the onset of hemostatic disorders in HSCT recipients or can even exacerbate the process. Nevertheless, their roles and detailed pathogenesis in the development of bleeding and thrombosis remain undefined and limited data in Asian population was known about the competing risks of thrombosis and bleeding.

Given the current understanding of hemostatic complication and many unknown mechanisms of relation between thrombosis and hemostasis,we undertook this prospective study to determine the incidence, predictor factors, specific pathogenesis, and survival specially for patients with thrombotic and bleeding complication to better improve outcomes.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
— 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients signed their informed consents are enrolled;
  • Patients suffering from hematological diseases and undergoing hematopoietic stem cell transplantation.

排除标准

  • Patients who have not signed their informed consents;
  • Patients with previous history of platelet disorder or bleeding diathesis;
  • Patients with inadequate renal function or hepatic function, or other essential organ damage.

研究组 & 干预措施

With hemostatic complications

The hemostatic and antithrombotic (thrombopoietin, interleukin-11, heparin) measures during HSCT.

干预措施: thrombopoietin, interleukin-11, heparin, (Drug)

结局指标

主要结局

The incidence of hemostatic complications in patients following HSCT.

时间窗: Two years after HSCT

次要结局

  • The severity of hemostatic complications in patients following HSCT.(Two years after HSCT)
  • The survival rates of patients with hemostatic complications following HSCT.(Two years after HSCT)

研究者

发起方
The First Affiliated Hospital of Soochow University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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