The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Value of Platelet Indices as Predictive Factor in Thrombocytopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05116033
Recruitment Status : Unknown
Verified November 2021 by Mahy nour Z Abed elhi,MD, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : November 10, 2021
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Mahy nour Z Abed elhi,MD, Assiut University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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)

Condition or disease
Main Focus of the Study

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 98 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Value of the Platelet Indices as a Predictive Factor in Adult Thrombocytopenic Patients
Estimated Study Start Date : December 20, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : December 30, 2022
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Participants of the study will be confirmed as thrombocytopenic patients.
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05116033


Contacts
Layout table for location contacts
Contact: Dalia G mahran, prof.dr 01007120821 daliagm2001@yahoo.com
Contact: safaa A ahmed 01064170058 safaakhaled2003@gmail.com

Sponsors and Collaborators
Assiut University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Mahy nour Z Abed elhi,MD, Value of the platelet indices as a prognostic factor in adult thrombocytopenic patients, Assiut University
ClinicalTrials.gov Identifier: NCT05116033    
Other Study ID Numbers: VOTIAAFITP
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No