Clinical trial NCT01571349: Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura
Official title: Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: rebalanced hemostasis
idiopathic thrombocytopenic purpura
coagulation status
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: maximum clot formation
timeFrame: within 3 hour of blood sampling
Secondary outcomes:
measure: platelet count
timeFrame: within 1 hours of blood sampling
measure: Coagulation battery results
timeFrame: within 1 hour after blood sampling
measure: von Willebrand factor antigen
timeFrame: within 3 hours of blood sample
measure: clotting time
timeFrame: within 3 hours of blood sampling
measure: alpha angle
timeFrame: within 3 hours of blood sample
measure: A10, A15, A20, A25
timeFrame: within 3 hours of blood sampling
measure: LY 60
timeFrame: within 3 hours of blood sampling
measure: CLI
timeFrame: within 3 hours of blood sampling
measure: Maximum lysis
timeFrame: within 3 hours of blood sampling
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Gaab Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: