Value of Platelet Indices as Predictive Factor in Thrombocytopenia

November 7, 2021 updated by: Mahy nour Z Abed elhi,MD, Assiut University

Value of the Platelet Indices as a Predictive Factor in Adult Thrombocytopenic Patients

Platelets are essential blood component involved in primary hemostasis. A platelet count of less than 150 × 109/L is considered to be thrombocytopenia The causes of thrombocytopenia can be divided into two major groups, a decreased production of platelets or an under proliferative BM and an over-destruction of platelets. Under proliferative BM defects most common cause is aplastic anemia, On the contrary, peripheral destruction of platelets may be as a result of an immune-mediated process namely immune thrombocytopenia (ITP)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

ITP is a common auto-immune disease in which platelet count is reduced in peripheral blood leading to petechiae and hemorrhage. The platelet count is decreased because there are auto-antibodies in circulation against platelets that bind to platelets surface and destroy them in the spleen . Aplastic anemia is characterized by suppression of bone marrow function resulting in progressive pancytopenia. The hematology analyzers can now give us certain parameters that can give information about platelets. These parameters are referred to as platelet indices in literature. Platelet indices include mean platelet volume (MPV), platelet distribution width (PDW) and platelet large cell ratio (P-LCR) . They are sensitive, non-invasive, inexpensive biomarkers. MPV is the most commonly investigated platelet parameter, signifies the average size of platelets in the blood. PDW is a marker of platelet anisocytosis, which describes distribution of platelets produced by megakaryocytes and increases upon platelet activation. P-LCR is another marker of platelet activity, is a percentage of all platelets with a volume measuring over 12 fl circulating in the bloodstream .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants of the study will be confirmed as thrombocytopenic patients.

Description

Inclusion Criteria:

  • Age more than 18 years old regardless of gender.
  • Platelet count below 100000/cu mm.
  • Confirmed diagnosis aplastic anaemia.
  • Confirmed diagnosis immune thrombocytopenia

Exclusion Criteria:

  • Patient who received a platelet or blood transfusion within two weeks prior MPV analysis.
  • Splenectomized patients
  • Patients with chronic infection or inflammations.
  • Diabetics and patients with coronary artery disease.
  • Patients on anti- platelet or anti-inflammatory drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of the prognostic predictive value of the platelet indices in thrombocytopenic patients.
Time Frame: 6months
• Exploring the validity of platelets indices as prognostic biomarkers in thrombocytopenic patients.
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VOTIAAFITP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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