- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05116033
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
Not yet recruiting
Conditions
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
Observational
Enrollment (Anticipated)
98
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dalia G mahran, prof.dr
- Phone Number: 01007120821
- Email: daliagm2001@yahoo.com
Study Contact Backup
- Name: safaa A ahmed
- Phone Number: 01064170058
- Email: safaakhaled2003@gmail.com
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
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
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
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
- Negash M, Tsegaye A, G/Medhin A. Diagnostic predictive value of platelet indices for discriminating hypo productive versus immune thrombocytopenia purpura in patients attending a tertiary care teaching hospital in Addis Ababa, Ethiopia. BMC Hematol. 2016 Jul 1;16:18. doi: 10.1186/s12878-016-0057-5. eCollection 2016.
- Norrasethada L, Khumpoo W, Rattarittamrong E, Rattanathammethee T, Chai-Adisaksopha C, Tantiworawit A. The use of mean platelet volume for distinguishing the causes of thrombocytopenia in adult patients. Hematol Rep. 2019 Mar 29;11(1):7732. doi: 10.4081/hr.2019.7732. eCollection 2019 Feb 19.
- Khan MI, Ullah I. Diagnostic importance of mean platelet volume, platelet distribution width and platelet large cell ratio as screening tool in immune thrombocytopenia. Porto Biomed J. 2020 Nov 24;5(6):e094. doi: 10.1097/j.pbj.0000000000000094. eCollection 2020 Nov-Dec.
- Pogorzelska K, Kretowska A, Krawczuk-Rybak M, Sawicka-Zukowska M. Characteristics of platelet indices and their prognostic significance in selected medical condition - a systematic review. Adv Med Sci. 2020 Sep;65(2):310-315. doi: 10.1016/j.advms.2020.05.002. Epub 2020 Jun 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 20, 2021
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
December 30, 2022
Study Registration Dates
First Submitted
September 15, 2021
First Submitted That Met QC Criteria
November 7, 2021
First Posted (Actual)
November 10, 2021
Study Record Updates
Last Update Posted (Actual)
November 10, 2021
Last Update Submitted That Met QC Criteria
November 7, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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