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

• ClinicalTrials.gov Identifier: NCT00789516
• Recruitment Status: Completed
• First Posted: November 13, 2008
• Last Update Posted: March 7, 2013
• Sponsor: Mahidol University
• Information provided by (Responsible Party): Nongnuch Sirachainan, Mahidol University

Tracking Information

• First Submitted Date: November 10, 2008
• First Posted Date: November 13, 2008
• Last Update Posted Date: March 7, 2013
• Study Start Date: June 2006
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 11, 2008): Level of protein C,S and AT, TAT, P1+2 and D-dimer [ Time Frame: 3 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Change of Coagulation Markers in Children With β-thalassemia Disease After Stem Cell Transplantation
• Official Title: The Change of Coagulation Markers in Children With β-thalassemia Disease After Stem Cell Transplantation
• Brief Summary: 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.
• 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).
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Blood

• 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.
• Condition: Thalassemia
• Intervention: Not Provided

Study Groups/Cohorts

• 1
  Normal control
• 2
  B thalassemia regular transfusion
• 3
  B thalassemia post transplantation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 11, 2008): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT00789516
• Other Study ID Numbers: ID11-48-16
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nongnuch Sirachainan, Mahidol University
• Original Responsible Party: Nongnuch Sirachainan, Ramathibodi hospital, Mahidol University
• Current Study Sponsor: Mahidol University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nongnuch Sirachainan, MD; Ramathibodi Hospital, Mahidol University

• PRS Account: Mahidol University
• Verification Date: March 2013