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OpenTrials
Completed

NCT Number: NCT03232359

Immature Platelet Fraction as a Promising Biomarker in Prediction Outcome of HELLP Syndrome

Immature platelet fraction is a non-invasive test of real time thrombopoiesis. High IPF% has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption. IPF% is able to discriminate between patients with TTP/HUS or SPE/HELLP

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Key information

About this study

Thrombotic microangiopathy (TMA) syndromes are extraordinarily diverse. Thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS) are the two most well known, and are considered to be the most serious. TTP-HUS occurs more commonly in women and among women is commonly associated with pregnancy.

Nevertheless, there are other pregnancy conditions that may manifest with TMA, including preeclampsia, eclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), in addition to acute fatty liver of pregnancy, antiphospholipid syndrome, and systemic lupus erythematosis.

Assessment of immature platelets was introduced as a non-invasive test of real time thrombopoiesis. They are newly released in the circulation with a larger size & greater RNA content than mature platelets, and can be measured by automated haematology analyzer equipped with reticulocyte detection channel and described as immature platelet fraction (%-IPF) and immature platelet count (A-IPC).

A high %-IPF has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption, while a low %-IPF is characteristic of bone marrow suppression states. %-IPF/A-IPF has the competency to be performed routinely and, therefore, can provide therapeutic and diagnostic feedback in the life threatening conditions.

The present study aimed to show the utility of estimating %-IPF and A-IPC using a reticulocyte detection channel CBC autoanalyzer as a simple reproducible blood analysis to be employed in the differential diagnosis of pregnancy-associated thrombotic microangiopathic conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Older than 20 years of age
  • Pregnant with singleton intrauterine pregnancy
  • More than 20 weeks of gestation

Exclusion criteria

  • Congenital malformation and fetuses with chromosomal or genetic syndrome.
  • Recent blood transfusion.
  • Refusal to participate in the study.
  • BMI <18.
  • Placental abnormalities like velamentous insertion.
  • Multiple pregnancies.
  • Known kidney disease.
  • History of auto immune disease.

Treatment and study plan

immature platelets fraction

Diagnostic Test

IPF-% and A-IPC using a reticulocyte detection channel CBC auto analyzer

Primary outcomes

  1. clinical response after delivery

    Time frame: 48 hours after delivery

    clinical and laboratory changes after delivery

Sponsors and collaborators

Lead sponsor

AYMAN ABDELKADER MOHAMED ABDELKADER

Other

Registry information

Official study title

Assessment of Immature Platelet Fraction in Pregnancy-Associated Thrombotic Microangiopathy

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 28, 2017
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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