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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

Tracking Information
First Submitted Date July 23, 2017
First Posted Date July 28, 2017
Last Update Posted Date July 28, 2017
Actual Study Start Date January 1, 2015
Actual Primary Completion Date December 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 26, 2017)
clinical response after delivery [ Time Frame: 48 hours after delivery ]
clinical and laboratory changes after delivery
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immature Platelet Fraction as a Promising Biomarker in Prediction Outcome of HELLP Syndrome
Official Title Assessment of Immature Platelet Fraction in Pregnancy-Associated Thrombotic Microangiopathy
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Weeks
Biospecimen Not Provided
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.

Condition
  • Pre-Eclampsia, Severe
  • HELLP Syndrome
  • Microangiopathy
Intervention Diagnostic Test: immature platelets fraction
IPF-% and A-IPC using a reticulocyte detection channel CBC auto analyzer
Study Groups/Cohorts
  • 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
    Intervention: Diagnostic Test: immature platelets fraction
  • 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
    Intervention: Diagnostic Test: immature platelets fraction
  • Control group
    This group included 20 pregnant women (gestational age of >20 weeks) having normal pregnancy with normal blood pressure and platelet count.
    Intervention: Diagnostic Test: immature platelets fraction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 26, 2017)
57
Original Actual Enrollment Same as current
Actual Study Completion Date June 1, 2016
Actual Primary Completion Date December 1, 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03232359
Other Study ID Numbers AAMABDELKADER 3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party AYMAN ABDELKADER MOHAMED ABDELKADER, Ain Shams Maternity Hospital
Study Sponsor AYMAN ABDELKADER MOHAMED ABDELKADER
Collaborators Not Provided
Investigators Not Provided
PRS Account Ain Shams Maternity Hospital
Verification Date July 2017