Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

Completed

• Conditions: Idiopathic Thrombocytopenic Purpura

• Registration Number: NCT01571349
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-24
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
maximum clot formation	within 3 hour of blood sampling	thromboelastography parameters performed within 3 hours of blood sampling

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of