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

Completed

• Conditions: HELLP Syndrome; Microangiopathy; Pre-Eclampsia, Severe
• Interventions: Diagnostic Test: immature platelets fraction

• Registration Number: NCT03232359
• Lead Sponsor: AYMAN ABDELKADER MOHAMED ABDELKADER

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2015-12-01
• Study Completion: 2016-06-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-23
• Study First Submitted QC: 2017-07-26
• Last Update Submitted: 2017-07-26
• Study First Posted: 2017-07-28
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TTP/HUS group	immature platelets fraction	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
Control group	immature platelets fraction	This group included 20 pregnant women (gestational age of \>20 weeks) having normal pregnancy with normal blood pressure and platelet count.
SPE/HELLP group	immature platelets fraction	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

Primary Outcome Measures

Name	Time	Method
clinical response after delivery	48 hours after delivery	clinical and laboratory changes after delivery