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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2016-06-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pre-Eclampsia, Severe HELLP Syndrome Microangiopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SPE/HELLP group

This group included 24 pregnant women (gestational age of \>20 weeks) who were diagnosed as having TMA with provisional diagnosis of pre-eclampsia, HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis

immature platelets fraction

Intervention Type DIAGNOSTIC_TEST

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

TTP/HUS group

This group included 13 pregnant women (gestational age of \>20 weeks) who were diagnosed as having TMA with provisional diagnosis of TTP/HUS. HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis

immature platelets fraction

Intervention Type DIAGNOSTIC_TEST

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

Control group

This group included 20 pregnant women (gestational age of \>20 weeks) having normal pregnancy with normal blood pressure and platelet count.

immature platelets fraction

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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immature platelets fraction

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes