Trials / Completed
CompletedNCT00789516
The Change of Coagulation Markers in Children With β-thalassemia Disease After Stem Cell Transplantation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- Mahidol University · Academic / Other
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Accepted
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).
Conditions
Timeline
- Start date
- 2006-06-01
- Primary completion
- 2009-03-01
- Completion
- 2009-12-01
- First posted
- 2008-11-13
- Last updated
- 2013-03-07
Locations
1 site across 1 country: Thailand
Source: ClinicalTrials.gov record NCT00789516. Inclusion in this directory is not an endorsement.