MPVNCT04126447
Platelet Indices in Decompensated Post Hepatitic Liver Cirrhosis
An observational study of MPV and PDW, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2019to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The aim of the present work is to study platelet indices as noninvasive predictors in decompensated post hepatitic liver cirrhosis .
Who may be able to join
- post hepatitic liver cirrhotic patients
Who cannot join
- renal failure patients
- pregnents
- diabetic patients
- patients with bone marrow disorders specially platelet disorders
- patient with other cause of liver cirrhosis
About this study
Official title: 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 .
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 .
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start30 Dec 2019 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MPVStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Nader Asham, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126447
- Sponsor's protocol ID
- Platelet in cirrosis
- Status last verified
- Oct 2019
- First submitted
- 4 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Indices ( Platelet Count - Mean Platelet Volume - Platelet Distribution Width ) in Decompensated Post Hepatitic Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04126447
- Acronym / sponsor ID
- Platelet in cirrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Dec 2019 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The aim of the present work is to study platelet indices as noninvasive predictors in decompensated post hepatitic liver cirrhosis .
Key inclusion criteria (1 listed)
- post hepatitic liver cirrhotic patients
Key exclusion criteria (5 listed)
- renal failure patients
- pregnents
- diabetic patients
- patients with bone marrow disorders specially platelet disorders
- patient with other cause of liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
platelet indices ( platelet count - mean platelet volume - platelet distribution width ) in decompensated post hepatitic liver cirrhosis
Time frame: 3 years
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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of MPV and PDW, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet indices ( platelet count - mean platelet volume - platelet distribution width ) in decompensated post hepatitic liver cirrhosis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.