Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

Sponsors

Lead sponsor: Samsung Medical Center

Source 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.

Overall Status Completed
Start Date April 2012
Completion Date December 2012
Primary Completion Date December 2012
Study Type Observational
Primary Outcome
Measure Time Frame
maximum clot formation within 3 hour of blood sampling
Secondary Outcome
Measure Time Frame
platelet count within 1 hours of blood sampling
Coagulation battery results within 1 hour after blood sampling
von Willebrand factor antigen within 3 hours of blood sample
clotting time within 3 hours of blood sampling
alpha angle within 3 hours of blood sample
A10, A15, A20, A25 within 3 hours of blood sampling
LY 60 within 3 hours of blood sampling
CLI within 3 hours of blood sampling
Maximum lysis within 3 hours of blood sampling
Enrollment 20
Condition
Eligibility

Sampling method: Probability Sample

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

Gender: All

Minimum age: 20 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Gaab Soo Kim, MD, PhD Principal Investigator Samsung Medical Center
Location
facility Samsung Medical Center
Location Countries

Korea, Republic of

Verification Date

December 2013

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Samsung Medical Center

Investigator full name: Gaab Soo Kim

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: chronic ITP group

Description: ITP patients with elevated level of vWF, ITP patients with preserved MA of thromboelastography

Arm group label: acute ITP group

Description: ITP patients with normal level of vWF, ITP patients with decreased MA of thromboelastography

Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov