NCT01571349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

8 months

First QC Date

April 2, 2012

Last Update Submit

December 24, 2013

Conditions

Idiopathic Thrombocytopenic Purpura

Keywords

rebalanced hemostasisidiopathic thrombocytopenic purpuracoagulation status

Outcome Measures

Primary Outcomes (1)

  • maximum clot formation

    thromboelastography parameters performed within 3 hours of blood sampling

    within 3 hour of blood sampling

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

chronic ITP group

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

acute ITP group

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

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Those with other causes of thrombocytopenia other than ITP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Gaab Soo Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 2, 2012

First Posted

April 5, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations

KR(1)