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Hemostatic Complications in Hematopoietic Stem Cell Transplantation (HCIHSCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281240
Recruitment Status : Unknown
Verified October 2015 by The First Affiliated Hospital of Soochow University.
Recruitment status was:  Recruiting
First Posted : November 2, 2014
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

Brief Summary:
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.

Condition or disease Intervention/treatment
Hemostatic Disorders Drug: thrombopoietin, interleukin-11, heparin,

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Time Perspective: Prospective
Official Title: Pathogenesis, Diagnosis, Management and Outcome of Hemostatic Complications in Hematopoietic Stem Cell Transplantation: A Prospective Study
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
With hemostatic complications
The hemostatic and antithrombotic (thrombopoietin, interleukin-11, heparin) measures during HSCT.
Drug: thrombopoietin, interleukin-11, heparin,
The hemostatic and antithrombotic (thrombopoietin, interleukin-11, heparin) measures during HSCT.
Other Name: TPO, IL-11




Primary Outcome Measures :
  1. The incidence of hemostatic complications in patients following HSCT. [ Time Frame: Two years after HSCT ]

Secondary Outcome Measures :
  1. The severity of hemostatic complications in patients following HSCT. [ Time Frame: Two years after HSCT ]
  2. The survival rates of patients with hemostatic complications following HSCT. [ Time Frame: Two years after HSCT ]


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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The incidence and severity of hemostatic complications in patients following HSCT.
Criteria

Inclusion Criteria:

  • 1. Patients signed their informed consents are enrolled; 2. Patients suffering from hematological diseases and undergoing hematopoietic stem cell transplantation.

Exclusion Criteria:

  • 1. Patients who have not signed their informed consents; 2. Patients with previous history of platelet disorder or bleeding diathesis; 3. Patients with inadequate renal function or hepatic function, or other essential organ damage.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281240


Contacts
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Contact: Yue Han, Professor +86 13901551669 hanyuesz@163.com

Locations
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China, Jiangsu
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Yue Han, professor    +86 13901551669    hanyuesz@163.com   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Investigators
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Principal Investigator: Jia Chen, Doctor The First Affiliated Hospital of Soochow University
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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT02281240    
Other Study ID Numbers: Soochowhy 2014
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015
Keywords provided by The First Affiliated Hospital of Soochow University:
Hematopoietic Stem Cell Transplantation
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Oprelvekin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents