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Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.

Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01933035
Enrollment
50
Registered
2013-08-30
Start date
2013-10-31
Completion date
2015-10-31
Last updated
2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aplastic Anaemia, Chemotherapy Induced Thrombocytopenia, Immune Thrombocytopenia, Myelodysplasia

Keywords

ITP, Thrombocytopenia, mean platelet mass, mean platelet component

Brief 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. 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.

Interventions

OTHERImmune Thrombocytopenics

Full blood count with extended platelet parameters

OTHERHypo-proliferative thrombocytopenics

Full blood count with extended platelet parameters

Full blood count with extended platelet parameters

Sponsors

Beth Israel Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* Suspected multifactorial thrombocytopenias and thrombocytopenia due to hypersplenism * Chronic active hepatitis * Those infected with HIV * Patients receiving concomitant radiotherapy * Gravid females * Congenital thrombocytopenias

Design outcomes

Primary

MeasureTime frame
Increased platelet density12 months

Secondary

MeasureTime frame
mean platelet mass12 months

Other

MeasureTime frame
Platelet mass distribution width12 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026