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Completed

NCT Number: NCT01571349

Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

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.

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Key information

Conditions

Idiopathic Thrombocytopenic Purpura Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those who visits the outpatients clinic of Samsung Medical Center with a diagnosis of idiopathic (immune) thrombocytopenic purpura (ITP)between March, 2012 and February, 2013.
  • Those with age between 20 and 70 yrs old

Exclusion criteria

  • Those with other causes of thrombocytopenia other than ITP

Treatment and study plan

Primary outcomes

  1. maximum clot formation

    Time frame: within 3 hour of blood sampling

    thromboelastography parameters performed within 3 hours of blood sampling

Secondary outcomes

  1. platelet count

    Time frame: within 1 hours of blood sampling

    platelet count

  2. Coagulation battery results

    Time frame: within 1 hour after blood sampling

    prothrombin time (%, second, INR) activated partial thromboplastin time (sec) fibrinogen level (mg/dL)

  3. von Willebrand factor antigen

    Time frame: within 3 hours of blood sample

    von Willebrand factor antigen level

  4. clotting time

    Time frame: within 3 hours of blood sampling

    clotting time of Thromboelastography

  5. alpha angle

    Time frame: within 3 hours of blood sample

    alpha angle of thromboelastography parameter

  6. A10, A15, A20, A25

    Time frame: within 3 hours of blood sampling

    amplitude 10, 15, 20, 25 minutes (mm) of thromboelastography parameter

  7. LY 60

    Time frame: within 3 hours of blood sampling

    maximum amplitude at 60 minutes of thromboelastography parameter

  8. CLI

    Time frame: within 3 hours of blood sampling

    clot lysis index of thromboelastography parameter

  9. Maximum lysis

    Time frame: within 3 hours of blood sampling

    Maximum lysis of thromboelastography parameter

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 5, 2012
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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