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

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ClinicalTrials.gov Identifier: NCT03232359
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
AYMAN ABDELKADER MOHAMED ABDELKADER, Ain Shams Maternity Hospital

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

Condition or disease Intervention/treatment
Pre-Eclampsia, Severe HELLP Syndrome Microangiopathy 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Weeks
Official Title: Assessment of Immature Platelet Fraction in Pregnancy-Associated Thrombotic Microangiopathy
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 1, 2015
Actual Study Completion Date : June 1, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. clinical response after delivery [ Time Frame: 48 hours after delivery ]
    clinical and laboratory changes after delivery



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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 Documents (Full-Text)

Documents provided by AYMAN ABDELKADER MOHAMED ABDELKADER, Ain Shams Maternity Hospital:
Study Protocol  [PDF] January 1, 2015
Statistical Analysis Plan  [PDF] May 1, 2016


Additional Information:

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Responsible Party: AYMAN ABDELKADER MOHAMED ABDELKADER, doctor, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03232359    
Other Study ID Numbers: AAMABDELKADER 3
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
HELLP Syndrome
Syndrome
Disease
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications