Immune ThrombocytopeniaNCT01933035
Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.
An observational study of Immune Thrombocytopenia and Chemotherapy Induced Thrombocytopenia, run by Beth Israel Medical Center at 1 site in United States.
Trial summary
To utilise extended platelet parameters in order to individuate Immune Thrombocytopenia (ITP) from hypo-proliferative causes of thrombocytopenia. To develop the clinical potential of the extended platelet parameters as they pertain to distinguishing different causes of thrombocytopenia from one another. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immune Thrombocytopenia, Chemotherapy Induced Thrombocytopenia, Myelodysplasia
- What is being tested?
- Immune Thrombocytopenics and Hypo-proliferative thrombocytopenics
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2015
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population would consist of adult female and male subjects of all ethnic persuasions in good general health apart from thrombocytopenia, bone marrow aplasia, myelodysplasia, or active malignancy requiring therapy. Vulnerable strata of the hospital population will not be recruited into the study.
Who may be able to join
- All individuals age 18yrs and above capable of rendering consent
- Known ITP confirmed by response to intravenous immune globulin (IVIG), glucocorticoids, or winRho and exclusion of all other possible causes of thrombocytopenia
- Confirmed aplastic anemia [as assessed through bone marrow trephine biopsy]
- Chemotherapy induced thrombocytopenia assessed at time of predicted nadir.
Who cannot join
- Suspected multifactorial thrombocytopenias and thrombocytopenia due to hypersplenism
- Chronic active hepatitis
- Those infected with HIV
- Patients receiving concomitant radiotherapy
- Gravid females
- Congenital thrombocytopenias
Trial locations and contacts
1 site in 1 country.
About this study
To utilise extended platelet parameters in order to individuate Immune Thrombocytopenia (ITP) from hypo-proliferative causes of thrombocytopenia.
To develop the clinical potential of the extended platelet parameters as they pertain to distinguishing different causes of thrombocytopenia from one another.
To test the hypothesis that mean platelet component (MPC) and mean platelet mass (MPM) might distinguish between thrombocytopenia related to bone marrow dysfunction and immune mediated destruction of platelets.
Read the detailed description
Patient to be registered at the Haematology-Oncology department Mount Sinai Roosevelt Hospital.
Inclusion criteria are as follows:
All individuals age 18yrs and above capable of rendering consent Known ITP confirmed by response to IVIG, glucocorticoids, or WinRho and exclusion of all other possible causes of thrombocytopenia Confirmed aplastic anemia [as assessed through bone marrow trephine biopsy]. Chemotherapy-induced thrombocytopenia assessed at time of predicted nadir.
- Conditions
- Immune Thrombocytopenia, Chemotherapy Induced Thrombocytopenia, Myelodysplasia, Aplastic Anaemia
- Being tested
- Immune Thrombocytopenics, Hypo-proliferative thrombocytopenics, Control Population
- Keywords
- ITP, Thrombocytopenia, mean platelet mass, mean platelet component
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Anemia, Refractory, with Excess of Blasts, Anemia, Aplastic, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune ThrombocytopenicsOther
Also called MPC (g/dl), MPM (pg)
Full blood count with extended platelet parameters
Hypo-proliferative thrombocytopenicsOther
Also called MPC (g/dl), MPM (pg)
Full blood count with extended platelet parameters
Control PopulationOther
Also called MPC (g/dl), MPM (pg)
Full blood count with extended platelet parameters
| Study group | Role | What they receive |
|---|---|---|
| Immune Thrombocytopenics | The study shall be a single institution prospective cohort study. Comparison will be made among individuals with known ITP . Those with known hypo-proliferative forms of thrombocytopenia [aplastic anaemia, chemotherapy induced thrombocytopenia, and myelodysplastic thrombocytopenia, and a control population. Receives: Other: Immune Thrombocytopenics | |
| Hypo-proliferative thrombocytopenics | The study shall be a single institution prospective cohort study. Comparison will be made between individuals with known ITP versus those with known hypo-proliferative forms of thrombocytopenia [aplastic anaemia, chemotherapy--induced thrombocytopenia, and myelodysplastic thrombocytopenia], and a control population. Receives: Other: Hypo-proliferative thrombocytopenics | |
| Control Pupulation | comprised of healthy individuals with normal platelet counts, to confirm normal values for MPC and MPM Receives: Other: Control Population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased platelet density
Measured: 12 months
Secondary outcomes (1)
mean platelet mass
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mala Varma, MD, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933035
- Sponsor's protocol ID
- 13-0134
- Status last verified
- May 2016
- First submitted
- 28 Aug 2013
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.
- ClinicalTrials.gov ID
- NCT01933035
- Acronym / sponsor ID
- 13-0134
- Conditions
- Immune Thrombocytopenia, Chemotherapy Induced Thrombocytopenia, Myelodysplasia, Aplastic Anaemia
- Keywords
- ITP, Thrombocytopenia, mean platelet mass, mean platelet component
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 Aug 2013 (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.
To utilise extended platelet parameters in order to individuate Immune Thrombocytopenia (ITP) from hypo-proliferative causes of thrombocytopenia.
To develop the clinical potential of the extended platelet parameters as they pertain to distinguishing different causes of thrombocytopenia from one another.
To test the hypothesis that mean platelet component (MPC) and mean platelet mass (MPM) might distinguish between thrombocytopenia related to bone marrow dysfunction and immune mediated destruction of platelets.
Detailed description
Patient to be registered at the Haematology-Oncology department Mount Sinai Roosevelt Hospital.
Inclusion criteria are as follows:
All individuals age 18yrs and above capable of rendering consent Known ITP confirmed by response to IVIG, glucocorticoids, or WinRho and exclusion of all other possible causes of thrombocytopenia Confirmed aplastic anemia [as assessed through bone marrow trephine biopsy]. Chemotherapy-induced thrombocytopenia assessed at time of predicted nadir.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immune Thrombocytopenics | – | Other: Immune ThrombocytopenicsThe study shall be a single institution prospective cohort study. Comparison will be made among individuals with known ITP . Those with known hypo-proliferative forms of thrombocytopenia [aplastic anaemia, chemotherapy induced thrombocytopenia, and myelodysplastic thrombocytopenia, and a control population. |
| Hypo-proliferative thrombocytopenics | – | Other: Hypo-proliferative thrombocytopenicsThe study shall be a single institution prospective cohort study. Comparison will be made between individuals with known ITP versus those with known hypo-proliferative forms of thrombocytopenia [aplastic anaemia, chemotherapy--induced thrombocytopenia, and myelodysplastic thrombocytopenia], and a control population. |
| Control Pupulation | – | Other: Control Populationcomprised of healthy individuals with normal platelet counts, to confirm normal values for MPC and MPM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population would consist of adult female and male subjects of all ethnic persuasions in good general health apart from thrombocytopenia, bone marrow aplasia, myelodysplasia, or active malignancy requiring therapy. Vulnerable strata of the hospital population will not be recruited into the study.
Key inclusion criteria (4 listed)
- All individuals age 18yrs and above capable of rendering consent
- Known ITP confirmed by response to intravenous immune globulin (IVIG), glucocorticoids, or winRho and exclusion of all other possible causes of thrombocytopenia
- Confirmed aplastic anemia [as assessed through bone marrow trephine biopsy]
- Chemotherapy induced thrombocytopenia assessed at time of predicted nadir.
Key exclusion criteria (6 listed)
- Suspected multifactorial thrombocytopenias and thrombocytopenia due to hypersplenism
- Chronic active hepatitis
- Those infected with HIV
- Patients receiving concomitant radiotherapy
- Gravid females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune ThrombocytopenicsAlso: MPC (g/dl), MPM (pg)Full blood count with extended platelet parameters | Other | Immune Thrombocytopenics |
| Hypo-proliferative thrombocytopenicsAlso: MPC (g/dl), MPM (pg)Full blood count with extended platelet parameters | Other | Hypo-proliferative thrombocytopenics |
| Control PopulationAlso: MPC (g/dl), MPM (pg)Full blood count with extended platelet parameters | Other | Control Pupulation |
Primary outcome
Increased platelet density
Time frame: 12 months
1 secondary outcome
mean platelet mass
Time frame: 12 months
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 17 May 2016.
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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.
Mala Varma, MD principal investigator
Beth Israel 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 Immune Thrombocytopenia and Chemotherapy Induced Thrombocytopenia, run by Beth Israel Medical Center at 1 site in United States.
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 4 inclusion and 6 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 17 May 2016. 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 United States. 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?
Increased platelet density (time frame: 12 months). 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 17 May 2016.