Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gaab Soo Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01571349
First received: April 2, 2012
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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.


Condition
Idiopathic Thrombocytopenic Purpura

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • maximum clot formation [ Time Frame: within 3 hour of blood sampling ] [ Designated as safety issue: No ]
    thromboelastography parameters performed within 3 hours of blood sampling


Secondary Outcome Measures:
  • platelet count [ Time Frame: within 1 hours of blood sampling ] [ Designated as safety issue: No ]
    platelet count

  • Coagulation battery results [ Time Frame: within 1 hour after blood sampling ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    von Willebrand factor antigen level

  • clotting time [ Time Frame: within 3 hours of blood sampling ] [ Designated as safety issue: No ]
    clotting time of Thromboelastography

  • alpha angle [ Time Frame: within 3 hours of blood sample ] [ Designated as safety issue: No ]
    alpha angle of thromboelastography parameter

  • A10, A15, A20, A25 [ Time Frame: within 3 hours of blood sampling ] [ Designated as safety issue: No ]
    amplitude 10, 15, 20, 25 minutes (mm) of thromboelastography parameter

  • LY 60 [ Time Frame: within 3 hours of blood sampling ] [ Designated as safety issue: No ]
    maximum amplitude at 60 minutes of thromboelastography parameter

  • CLI [ Time Frame: within 3 hours of blood sampling ] [ Designated as safety issue: No ]
    clot lysis index of thromboelastography parameter

  • Maximum lysis [ Time Frame: within 3 hours of blood sampling ] [ Designated as safety issue: No ]
    Maximum lysis of thromboelastography parameter


Enrollment: 20
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
chronic ITP group
ITP patients with elevated level of vWF, ITP patients with preserved MA of thromboelastography
acute ITP group
ITP patients with normal level of vWF, ITP patients with decreased MA of thromboelastography

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Those who visits the outpatients clinic of Samsung Medical Center with a diagnosis of idiopathic (immune) thrombocytopenic purpura between March, 2012 and February, 2013.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571349

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Gaab Soo Kim, MD, PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Gaab Soo Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01571349     History of Changes
Other Study ID Numbers: 2012-02--85-001
Study First Received: April 2, 2012
Last Updated: December 24, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
rebalanced hemostasis
idiopathic thrombocytopenic purpura
coagulation status

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014