Clinical Trial: Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

Brief Summary: The investigators are trying to investigate the coagulation status of idiopathic (immune) thrombocytopenic purpura patients by measuring the platelet count, coagulation battery, von Willebrand factor level, thromboelastography.

Detailed Summary: In patients with chronic coagulation disorder, laboratory model and clinical data have shown evidence for a rebalanced hemostasis. Previous study showed that the platelet count may not predict the risk of bleeding since the platelet count is not an indicator of platelet function. Thromboelastography may be the choice of investigation when platelet function is in question especially in patients with idiopathic (immune) thrombocytopenic purpura (ITP). Previous study have shown that maximum clot formation is the most important thromboelastography parameter in predicting bleeding in ITP patients that makes thromboelastography superior to other hemostatic tests. The investigators are trying to evaluate the rebalanced hemostasis in patients with ITP by comparing the value of platelet count, von Willebrand factor antigen level, and thromboelastography parameters.
Sponsor: Samsung Medical Center

Current Primary Outcome: maximum clot formation [ Time Frame: within 3 hour of blood sampling ]

thromboelastography parameters performed within 3 hours of blood sampling


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • platelet count [ Time Frame: within 1 hours of blood sampling ]
    platelet count
  • Coagulation battery results [ Time Frame: within 1 hour after blood sampling ]
    prothrombin time (%, second, INR) activated partial thromboplastin time (sec) fibrinogen level (mg/dL)
  • von Willebrand factor antigen [ Time Frame: within 3 hours of blood sample ]
    von Willebrand factor antigen level
  • clotting time [ Time Frame: within 3 hours of blood sampling ]
    clotting time of Thromboelastography
  • alpha angle [ Time Frame: within 3 hours of blood sample ]
    alpha angle of thromboelastography parameter
  • A10, A15, A20, A25 [ Time Frame: within 3 hours of blood sampling ]
    amplitude 10, 15, 20, 25 minutes (mm) of thromboelastography parameter
  • LY 60 [ Time Frame: within 3 hours of blood sampling ]
    maximum amplitude at 60 minutes of thromboelastography parameter
  • CLI [ Time Frame: within 3 hours of blood sampling ]
    clot lysis index of thromboelastography parameter
  • Maximum lysis [ Time Frame: within 3 hours of blood sampling ]
    Maximum lysis of thromboelastography parameter


Original Secondary Outcome: Same as current

Information By: Samsung Medical Center

Dates:
Date Received: April 2, 2012
Date Started: April 2012
Date Completion:
Last Updated: December 24, 2013
Last Verified: December 2013