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Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01571349
Enrollment
20
Registered
2012-04-05
Start date
2012-04-30
Completion date
2012-12-31
Last updated
2013-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Thrombocytopenic Purpura

Keywords

rebalanced hemostasis, idiopathic thrombocytopenic purpura, coagulation status

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 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.

Interventions

None listed

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
maximum clot formationwithin 3 hour of blood samplingthromboelastography parameters performed within 3 hours of blood sampling

Secondary

MeasureTime frameDescription
Coagulation battery resultswithin 1 hour after blood samplingprothrombin time (%, second, INR) activated partial thromboplastin time (sec) fibrinogen level (mg/dL)
von Willebrand factor antigenwithin 3 hours of blood samplevon Willebrand factor antigen level
clotting timewithin 3 hours of blood samplingclotting time of Thromboelastography
alpha anglewithin 3 hours of blood samplealpha angle of thromboelastography parameter
platelet countwithin 1 hours of blood samplingplatelet count
LY 60within 3 hours of blood samplingmaximum amplitude at 60 minutes of thromboelastography parameter
CLIwithin 3 hours of blood samplingclot lysis index of thromboelastography parameter
Maximum lysiswithin 3 hours of blood samplingMaximum lysis of thromboelastography parameter
A10, A15, A20, A25within 3 hours of blood samplingamplitude 10, 15, 20, 25 minutes (mm) of thromboelastography parameter

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026