Platelet IndicesNCT04335955
Platelet Indices in Prediction of Mortality in Critically Ill Septic Patients
An observational study of Platelet Indices and Mortality, run by Amany Faheem at 1 site in Egypt.
Trial summary
Platelets (PLT), a major and essential constituent of blood, plays an important role in physiological and pathological processes such as coagulation, thrombosis, inflammation and maintenance of vascular endothelial cells the integrity (1). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Platelet Indices, Mortality, Sepsis
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 30 Nov 2020
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: Sepsis: life-threatening organ dysfunction caused by a dysregulated host response to infection. According to the 2016 consensus definitions, an increase in SOFA score of 2 or more constitutes organ dysfunction
Who may be able to join
- patients aged 18-65 years ICU stay more than 24 hours septic patients according to Third International Consensus Definitions Septic Shock patients according to Third International Consensus Definitions
Who cannot join
- Pregnant women
- Patients with active hemorrhage
- Patients with hematological diseases (including anemia, hypersplenism
- Lymphoma or leukemia
- Rheumatism, and bone marrow diseases)
- Patients who had infused with blood or platelets prior to their admission
- Patients who had used anti-platelet drugs prior to their admission
- Patients who had received radiotherapy or chemotherapy or bone marrow transplantation 1 month prior to admission.
Trial locations and contacts
1 site in 1 country.
About this study
Platelets (PLT), a major and essential constituent of blood, plays an important role in physiological and pathological processes such as coagulation, thrombosis, inflammation and maintenance of vascular endothelial cells the integrity (1).
Platelet indices are a group of parameters that are used to measure the total amount of PLTs, PLTs morphology and proliferation kinetics (2).
Read more
The commonly used PLT indices include PLT count, mean platelet volume (MPV), platelet distribution width (PDW), and plateletcrit (PCT). The MPV refers to the ratio of PCT to PLT count. PDW is numerically equal to the coefficient of PLT volume variation, which is used to describe the dispersion of PLTs volume (3).
It is well known that platelet indices have been applied in the diagnosis of hematological system diseases. In recent years, it has been discovered that these indices are related to the severity of illness and patients' prognosis. Reduction in PLT count is an independent risk factor for critically ill patients in intensive care unit (4).
In addition, Acute Physiology and Chronic Health Evaluation II (APACHE II) System also includes thrombocytopenia as an independent risk factor for mortality (5).
In a recent research, it will be reported that MPV will be rising with interleukin-6 and C-reactive protein in septic premature infants. MPV has been used as predictor of many inflammatory diseases as MPV significantly higher on both day 1 and day 3 in neonatal sepsis (6).
In addition, in patients with cirrhosis and ascites, elevated PDW and MPV will be accurate diagnostic predictors for ascetic fluid infection (7).
MPV and PDW will be used as biomarkers predicting the development of postoperative sepsis in colorectal cancer patient (8).
All these evidences indicated that PLT indices will be considered as indicator in a series of diseases (9).
Advantages of platelet indices are simple, available, cheap tools and routinely done in the hospital laboratory in all critical ill patients and may be a useful, sensitive tool for diagnosis and monitoring these patients especially in limited resource countries as Egypt. However, whether PLT indices are correlated with procalcitonin in assessment the severity of illness is still under research in septic patients
Read the detailed description
Blood will be drawn from the peripheral vein, arterial or a central catheter for evaluation of whole blood count, C-reactive protein (CRP), and procalcitonin serum levels. This procedure will be done at diagnosis, 3, 7, 14, 21 and 28 days of sepsis.
The following data will be recorded:
- Demographic data (age, gender and BMI) and cause of sepsis
- Procalcitonin and its correlation with changes in platelet indices
- The odds ratio (OR) for mortality in patients with normal and abnormal platelet indices.
- Sequential organ failure assessment (SOFA) scores.
- Conditions
- Platelet Indices, Mortality, Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between platelet indices and 30 days mortality among critically ill septic patients
The correlation between platelet indices and 30 days mortality among critically ill septic patients
Measured: within 30 days from hospital admission
Secondary outcomes (3)
Correlation between platelet indices and Length of ICU stay (days)
Correlation between platelet indices and Length of ICU stay (days)
Measured: within 30 days from hospital admission
Correlation between platelet indices and detection of organs dysfunction
Correlation between platelet indices and detection of organs dysfunction
Measured: within 30 days from hospital admission
Correlation between platelet indices and procalcitonin.
Correlation between platelet indices and procalcitonin.
Measured: within 30 days from hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 May 2020
- Primary completion31 Oct 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet IndicesStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amany Faheem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amany Faheem, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335955
- Sponsor's protocol ID
- Platelet Indices in sepsis
- Status last verified
- Nov 2023
- First submitted
- 3 Apr 2020
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Indices in Prediction of Mortality in Critically Ill Septic Patients
- ClinicalTrials.gov ID
- NCT04335955
- Acronym / sponsor ID
- Platelet Indices in sepsis
- Conditions
- Platelet Indices, Mortality, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Amany FaheemUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 7 Apr 2020 (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.
Platelets (PLT), a major and essential constituent of blood, plays an important role in physiological and pathological processes such as coagulation, thrombosis, inflammation and maintenance of vascular endothelial cells the integrity (1).
Platelet indices are a group of parameters that are used to measure the total amount of PLTs, PLTs morphology and proliferation kinetics (2).
The commonly used PLT indices include PLT count, mean platelet volume (MPV), platelet distribution width (PDW), and plateletcrit (PCT). The MPV refers to the ratio of PCT to PLT count. PDW is numerically equal to the coefficient of PLT volume variation, which is used to describe the dispersion of PLTs volume (3).
It is well known that platelet indices have been applied in the diagnosis of hematological system diseases. In recent years, it has been discovered that these indices are related to the severity of illness and patients' prognosis. Reduction in PLT count is an independent risk factor for critically ill patients in intensive care unit (4).
In addition, Acute Physiology and Chronic Health Evaluation II (APACHE II) System also includes thrombocytopenia as an independent risk factor for mortality (5).
In a recent research, it will be reported that MPV will be rising with interleukin-6 and C-reactive protein in septic premature infants. MPV has been used as predictor of many inflammatory diseases as MPV significantly higher on both day 1 and day 3 in neonatal sepsis (6).
In addition, in patients with cirrhosis and ascites, elevated PDW and MPV will be accurate diagnostic predictors for ascetic fluid infection (7).
MPV and PDW will be used as biomarkers predicting the development of postoperative sepsis in colorectal cancer patient (8).
All these evidences indicated that PLT indices will be considered as indicator in a series of diseases (9).
Advantages of platelet indices are simple, available, cheap tools and routinely done in the hospital laboratory in all critical ill patients and may be a useful, sensitive tool for diagnosis and monitoring these patients especially in limited resource countries as Egypt. However, whether PLT indices are correlated with procalcitonin in assessment the severity of illness is still under research in septic patients
Detailed description
Blood will be drawn from the peripheral vein, arterial or a central catheter for evaluation of whole blood count, C-reactive protein (CRP), and procalcitonin serum levels. This procedure will be done at diagnosis, 3, 7, 14, 21 and 28 days of sepsis.
The following data will be recorded:
- Demographic data (age, gender and BMI) and cause of sepsis
- Procalcitonin and its correlation with changes in platelet indices
- The odds ratio (OR) for mortality in patients with normal and abnormal platelet indices.
- Sequential organ failure assessment (SOFA) scores.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Sepsis: life-threatening organ dysfunction caused by a dysregulated host response to infection. According to the 2016 consensus definitions, an increase in SOFA score of 2 or more constitutes organ dysfunction
Key inclusion criteria (1 listed)
- patients aged 18-65 years ICU stay more than 24 hours septic patients according to Third International Consensus Definitions Septic Shock patients according to Third International Consensus Definitions
Key exclusion criteria (8 listed)
- Pregnant women
- Patients with active hemorrhage
- Patients with hematological diseases (including anemia, hypersplenism
- Lymphoma or leukemia
- Rheumatism, and bone marrow diseases)
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
The correlation between platelet indices and 30 days mortality among critically ill septic patients
Time frame: within 30 days from hospital admission
The correlation between platelet indices and 30 days mortality among critically ill septic patients
3 secondary outcomes
Correlation between platelet indices and Length of ICU stay (days)
Time frame: within 30 days from hospital admission
Correlation between platelet indices and detection of organs dysfunction
Time frame: within 30 days from hospital admission
Correlation between platelet indices and procalcitonin.
Time frame: within 30 days from hospital admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Indices and Mortality, run by Amany Faheem at 1 site in Egypt.
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 8 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: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The correlation between platelet indices and 30 days mortality among critically ill septic patients (time frame: within 30 days from hospital admission). 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 24 Nov 2023.