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

HELLP Syndrome Clinical Trial

Official title:

Assessment of Immature Platelet Fraction in Pregnancy-Associated Thrombotic Microangiopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232359
• Other study ID #: AAMABDELKADER 3
• Status: Completed
• Phase: N/A
• First received: July 23, 2017
• Last updated: July 26, 2017
• Start date: January 1, 2015
• Est. completion date: June 1, 2016

Study information

• Verified date: July 2017
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 1, 2016
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• HELLP Syndrome
• Microangiopathy
• Pre-Eclampsia
• Pre-Eclampsia, Severe
• Syndrome
• Thrombotic Microangiopathies
• Vascular Diseases

Intervention

Diagnostic Test:
• immature platelets fraction
IPF-% and A-IPC using a reticulocyte detection channel CBC auto analyzer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AYMAN ABDELKADER MOHAMED ABDELKADER

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical response after delivery	clinical and laboratory changes after delivery	48 hours after delivery