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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
History of Changes
  Purpose

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.


Condition
Thalassemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Change of Coagulation Markers in Children With β-thalassemia Disease After Stem Cell Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Thalassemia
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Level of protein C,S and AT, TAT, P1+2 and D-dimer [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Blood


Enrollment: 60
Study Start Date: June 2006
Study Completion Date: December 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Normal control
2
B thalassemia regular transfusion
3
B thalassemia post transplantation

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789516

Locations
Thailand
Department of Pediatrics, Ramathibodi hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Nongnuch Sirachainan, MD Ramathibodi Hospital, Mahidol University
  More Information

No publications provided

Responsible Party: Nongnuch Sirachainan, Associate Prof, Mahidol University
ClinicalTrials.gov Identifier: NCT00789516     History of Changes
Other Study ID Numbers: ID11-48-16
Study First Received: November 10, 2008
Last Updated: March 6, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Coagulation markers, thalassemia disease post SCT

Additional relevant MeSH terms:
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 19, 2013