Hemostatic Complications in Hematopoietic Stem Cell Transplantation

NCT02281240 | Unknown

• 1 other identifier: Soochowhy 2014
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemostatic Disorders

Keywords

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• The incidence of hemostatic complications in patients following HSCT.

  Two years after HSCT

Secondary Outcomes (2)

• 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

Study Arms (1)

With hemostatic complications

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

Drug: thrombopoietin, interleukin-11, heparin,

Interventions

thrombopoietin, interleukin-11, heparin, DRUG

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

Also known as: TPO, IL-11

With hemostatic complications

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The incidence and severity of hemostatic complications in patients following HSCT.

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

Thrombopoietin; Interleukin-11; Heparin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Interleukins; Glycosaminoglycans; Polysaccharides

Study Officials

• Jia Chen, Doctor

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Han, Professor

CONTACT

+86 13901551669; hanyuesz@163.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: November 3, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

CN (1)