Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official title:

Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571349
• Other study ID #: 2012-02--85-001
• Status: Completed
• Phase: N/A
• First received: April 2, 2012
• Last updated: December 24, 2013
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum clot formation	thromboelastography parameters performed within 3 hours of blood sampling	within 3 hour of blood sampling	No
Secondary	platelet count	platelet count	within 1 hours of blood sampling	No
Secondary	Coagulation battery results	prothrombin time (%, second, INR) activated partial thromboplastin time (sec) fibrinogen level (mg/dL)	within 1 hour after blood sampling	No
Secondary	von Willebrand factor antigen	von Willebrand factor antigen level	within 3 hours of blood sample	No
Secondary	clotting time	clotting time of Thromboelastography	within 3 hours of blood sampling	No
Secondary	alpha angle	alpha angle of thromboelastography parameter	within 3 hours of blood sample	No
Secondary	A10, A15, A20, A25	amplitude 10, 15, 20, 25 minutes (mm) of thromboelastography parameter	within 3 hours of blood sampling	No
Secondary	LY 60	maximum amplitude at 60 minutes of thromboelastography parameter	within 3 hours of blood sampling	No
Secondary	CLI	clot lysis index of thromboelastography parameter	within 3 hours of blood sampling	No
Secondary	Maximum lysis	Maximum lysis of thromboelastography parameter	within 3 hours of blood sampling	No