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

Assessment of Immature Platelet Fraction in Pregnancy-Associated Thrombotic Microangiopathy

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

Study Overview

• Status: Completed
• Conditions: HELLP Syndrome; Microangiopathy; Pre-Eclampsia, Severe
• Intervention / Treatment: Diagnostic test: immature platelets fraction

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 Type: Observational
• Enrollment (Actual): 57

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Group 1: 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.

Group 2: 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.

Group 3: Control group. This group included 20 pregnant women (gestational age of >20 weeks) having normal pregnancy with normal blood pressure and platelet count.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: immature platelets fraction; 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	Diagnostic test: immature platelets fraction; 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.	Diagnostic test: immature platelets fraction; IPF-% and A-IPC using a reticulocyte detection channel CBC auto analyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical response after delivery	clinical and laboratory changes after delivery	48 hours after delivery

Collaborators and Investigators

• Sponsor: AYMAN ABDELKADER MOHAMED ABDELKADER

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 23, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Pregnancy Complications; Hypertension, Pregnancy-Induced; Syndrome; Eclampsia; Pre-Eclampsia; HELLP Syndrome
• Other Study ID Numbers: AAMABDELKADER 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No