Idiopathic Thrombocytopenic PurpuraNCT01571349
Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura
An observational study of Idiopathic Thrombocytopenic Purpura, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Those with other causes of thrombocytopenia other than ITP
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Keywords
- rebalanced hemostasis, idiopathic thrombocytopenic purpura, coagulation status
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum clot formation
thromboelastography parameters performed within 3 hours of blood sampling
Measured: within 3 hour of blood sampling
Secondary outcomes (9)
platelet count
platelet count
Measured: within 1 hours of blood sampling
Coagulation battery results
prothrombin time (%, second, INR) activated partial thromboplastin time (sec) fibrinogen level (mg/dL)
Measured: within 1 hour after blood sampling
von Willebrand factor antigen
von Willebrand factor antigen level
Measured: within 3 hours of blood sample
clotting time
clotting time of Thromboelastography
Measured: within 3 hours of blood sampling
alpha angle
alpha angle of thromboelastography parameter
Measured: within 3 hours of blood sample
A10, A15, A20, A25
amplitude 10, 15, 20, 25 minutes (mm) of thromboelastography parameter
Measured: within 3 hours of blood sampling
LY 60
maximum amplitude at 60 minutes of thromboelastography parameter
Measured: within 3 hours of blood sampling
CLI
clot lysis index of thromboelastography parameter
Measured: within 3 hours of blood sampling
Maximum lysis
Maximum lysis of thromboelastography parameter
Measured: within 3 hours of blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaab Soo Kim, Samsung Medical Center
- Investigators
- Gaab Soo Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571349
- Sponsor's protocol ID
- 2012-02--85-001
- Status last verified
- Dec 2013
- First submitted
- 2 Apr 2012
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT01571349
- Acronym / sponsor ID
- 2012-02--85-001
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Keywords
- rebalanced hemostasis, idiopathic thrombocytopenic purpura, coagulation status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Those with other causes of thrombocytopenia other than ITP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
maximum clot formation
Time frame: within 3 hour of blood sampling
thromboelastography parameters performed within 3 hours of blood sampling
9 secondary outcomes
platelet count
Time frame: within 1 hours of blood sampling
Coagulation battery results
Time frame: within 1 hour after blood sampling
von Willebrand factor antigen
Time frame: within 3 hours of blood sample
clotting time
Time frame: within 3 hours of blood sampling
alpha angle
Time frame: within 3 hours of blood sample
A10, A15, A20, A25
Time frame: within 3 hours of blood sampling
LY 60
Time frame: within 3 hours of blood sampling
CLI
Time frame: within 3 hours of blood sampling
Maximum lysis
Time frame: within 3 hours of blood sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaab Soo Kim, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Thrombocytopenic Purpura, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum clot formation (time frame: within 3 hour of blood sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2013.