The Change of Coagulation Markers in Children With β-thalassemia Disease After Stem Cell Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nongnuch Sirachainan, Mahidol University
ClinicalTrials.gov Identifier:
NCT00789516
First received: November 10, 2008
Last updated: March 6, 2013
Last verified: March 2013

November 10, 2008
March 6, 2013
June 2006
March 2009   (final data collection date for primary outcome measure)
Level of protein C,S and AT, TAT, P1+2 and D-dimer [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00789516 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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The Change of Coagulation Markers in Children With β-thalassemia Disease After Stem Cell Transplantation
The Change of Coagulation Markers in Children With β-thalassemia Disease After Stem Cell Transplantation

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.

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).

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Blood

Probability Sample

The subjects were classified into 3 groups; β-thalassemia post SCT (Thal-SCT), β-thalassemia treated with regular transfusion (Thal-RT) and NC.

Thalassemia
Not Provided
  • 1
    Normal control
  • 2
    B thalassemia regular transfusion
  • 3
    B thalassemia post transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Children with beta thalassemia major or beta thalassemia / Hb E who have co-diseases such as immune hemolytic anemia, infection, or inflammatory diseases

Both
1 Year to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00789516
ID11-48-16
No
Nongnuch Sirachainan, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Nongnuch Sirachainan, MD Ramathibodi Hospital, Mahidol University
Mahidol University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP