Hemostatic Disorders Clinical Trial
Official title:
Pathogenesis, Diagnosis, Management and Outcome of Hemostatic Complications in Hematopoietic Stem Cell Transplantation: A Prospective Study
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.
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.
;
Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01919840 -
Blood Products Transfusion in Cardiac Surgery After the Implementation of a Coagulation Monitoring System at Patient Bedside: Thromboelastometry Versus Standard Transfusion Protocol
|
Phase 4 | |
| Recruiting |
NCT06271252 -
A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study
|
Phase 1 |