ClinicalTrials.gg
Status unknownNCT04126447Updated Oct 15, 2019

Platelet Indices in Decompensated Post Hepatitic Liver Cirrhosis

An observational study in MPV and PDW, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-15.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the present work is to study platelet indices ( platelet count - mean platelet volume - platelet distribution width ) as noninvasive predictors in decompensated post hepatitic liver cirrhosis .

Read the detailed description

Cirrhosis is an advanced liver disease characterized by fibrosis and alteration in hepatic architecture with the development of structurally anomalous nodules . Ascites is a condition in which pathological collection of fluid occurs within the peritoneal cavity mainly because of portal hypertension. It is a major complication of liver cirrhosis, The appearance of ascites in cirrhotic patients indicates a poor prognosis , Spontaneous bacterial peritonitis is a severe infection, commonly occurring in cirrhotic ascitic patients.

Platelets are attributed to preserve hemostasis. Yet, recently, there has been growing recognition that they also play an essential role in inflammatory and immune response. Platelets release prothrombotic and proinflammatory agents and participate in the induction and advancement of vascular and inflammatory disorders . Larger-sized platelets contain many granules, and are therefore more efficient in their hemostatic and proinflammatory actions . This is why the mean platelet volume (MPV) and platelet distribution width (PDW) are worth considering as potential tests for platelet function and activation .

The MPV and PWD can be calculated using almost all automated hematology analyzers. The MPV indicates the average platelet size in femtoliters. The PDW, reflecting homogeneity of platelet size, is calculated from the MPV by the equation (SD of platelet volume divided by MPV×100) or the distribution width at 20% frequency .

02

Conditions studied

  • MPV
  • PDW
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The aim of the present work is to study platelet indices as noninvasive predictors in decompensated post hepatitic liver cirrhosis .

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • post hepatitic liver cirrhotic patients

Exclusion criteria

Exclusion Criteria:

  • renal failure patients
  • pregnents
  • diabetic patients
  • patients with bone marrow disorders specially platelet disorders
  • patient with other cause of liver cirrhosis
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. platelet indices ( platelet count - mean platelet volume - platelet distribution width ) in decompensated post hepatitic liver cirrhosis

    The aim of the present work is to study platelet indices ( platelet count - mean platelet volume - platelet distribution width ) as noninvasive predictors in decompensated post hepatitic liver cirrhosis .

    Time frame: 3 years

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2019; primary completion for Aug 2022, 32 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2019
First posted
Oct 15, 2019
StartEst.
Dec 30, 2019
Primary completionEst.
Aug 31, 2022
CompletionEst.
Sep 30, 2022
Last update
Oct 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04126447
Lead sponsor
Assiut University
Responsible party
Marina Nader Asham (principle investigator, Assiut University) — Principal investigator
First posted
Oct 15, 2019
Start date
Dec 30, 2019 (estimated)
Primary completion
Aug 31, 2022 (estimated)
Completion
Sep 30, 2022 (estimated)
Last update
Oct 15, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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