Critically Ill PatientsNCT02016859
Observational Prospective Study of the Predicted Value of Immature Thrombocytes Counts in Three Different Groups of Critically Ill Patients
An observational study of Critically Ill Patients and Neutropenic Fever Patients, run by Dr. Yishai Ofran at 1 site in Israel.
Trial summary
Immature Platelet Fraction (IPF) is a new value in CBC blood tests Recent Studies showed that this value may be another prognostic factor in critically ill patients such as those admitted to ICU, or those with neutropenic Fever. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients, Neutropenic Fever Patients, Patients With Hip Fractures
- What is being tested?
- Immature Platelet Fraction
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Nov 2014
- How long will I take part?
- 6 Months
- 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: admmitted patients to multiple departements
Who may be able to join
- Admission to hospital blood sample is taken between 24:00 pm till 15:00 pm
Who cannot join
- blood sample is taken after 15:00 pm in the first day of admission during the week
- blood sample is taken on weekend: thursday 15:00 pm till saturday 24:00 pm
Trial locations and contacts
1 site in 1 country.
About this study
Immature Platelet Fraction (IPF) is a new value in CBC blood tests Recent Studies showed that this value may be another prognostic factor in critically ill patients such as those admitted to ICU, or those with neutropenic Fever.
The purpose of the study is to check if the IPF may be used as a prognostic Factor in these patients
Read the detailed description
In this study we have 3 groups of patients
- Patients admitted to ICU
- Patients admitted with neutropenic fever
- Patients admitted with hip fractures it is a prospective study, not interventional, we'll take blood samples of these patients including CBC count eith IPF and other inflammation markers such as CRP and we'll compare CRP to IPF in addition to clinical follow-up of the patient till discharge.
At the end of this study we'll compare the efficacy of IPF as a prognostic Factor in these patients
- Being tested
- Immature Platelet Fraction
- Keywords
- IPF Immature platelet fraction, ICU neutropenic fever, hip fracture, critically ill
- Medical subject headings
- Hip Fractures, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immature Platelet FractionOther
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients admitted to ICU | those patients who are admitted to ICU with multiorgan failure/injury Receives: Other: Immature Platelet Fraction | |
| Neutropinc Fever patients | admitted to ER, haemato-oncology or oncology Receives: Other: Immature Platelet Fraction | |
| Patients of Hip's Fracture | admitted to orthopedic departement Receives: Other: Immature Platelet Fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery from sepsis or time to death
the primary outcome is the result of the patient's admission on which data analysis will be based
Measured: 6 months
Secondary outcomes (1)
Predicting value of IPF for prognosis
after the analysis of the data we'll may ba able to assess the predicting value of the IPF in predicting severity of infection and prediciting prognosis of infection in the three groups described
Measured: baeline 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionMay 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critically Ill PatientsStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Dr. Yishai Ofran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Yishai Ofran, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016859
- Sponsor's protocol ID
- IPF-2013-Rambam
- Status last verified
- Dec 2013
- First submitted
- 10 Nov 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Di Mario A, Garzia M, Leone F, Arcangeli A, Pagano L, Zini G. Immature platelet fraction (IPF) in hospitalized patients with neutrophilia and suspected bacterial infection. J Infect. 2009 Sep;59(3):201-6. doi: 10.1016/j.jinf.2009.07.007. Epub 2009 Jul 18.
PubMed 19647322De Blasi RA, Cardelli P, Costante A, Sandri M, Mercieri M, Arcioni R. Immature platelet fraction in predicting sepsis in critically ill patients. Intensive Care Med. 2013 Apr;39(4):636-43. doi: 10.1007/s00134-012-2725-7. Epub 2012 Oct 24.
PubMed 23093245
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study of the Predicted Value of Immature Thrombocytes Counts in Three Different Groups of Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02016859
- Acronym / sponsor ID
- IPF-2013-Rambam
- Keywords
- IPF Immature platelet fraction, ICU neutropenic fever, hip fracture, critically ill
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Dr. Yishai OfranUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 20 Dec 2013 (estimated)
- 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.
Immature Platelet Fraction (IPF) is a new value in CBC blood tests Recent Studies showed that this value may be another prognostic factor in critically ill patients such as those admitted to ICU, or those with neutropenic Fever.
The purpose of the study is to check if the IPF may be used as a prognostic Factor in these patients
Detailed description
In this study we have 3 groups of patients
- Patients admitted to ICU
- Patients admitted with neutropenic fever
- Patients admitted with hip fractures it is a prospective study, not interventional, we'll take blood samples of these patients including CBC count eith IPF and other inflammation markers such as CRP and we'll compare CRP to IPF in addition to clinical follow-up of the patient till discharge.
At the end of this study we'll compare the efficacy of IPF as a prognostic Factor in these patients
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients admitted to ICU | – | Other: Immature Platelet Fractionthose patients who are admitted to ICU with multiorgan failure/injury |
| Neutropinc Fever patients | – | Other: Immature Platelet Fractionadmitted to ER, haemato-oncology or oncology |
| Patients of Hip's Fracture | – | Other: Immature Platelet Fractionadmitted to orthopedic departement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- admmitted patients to multiple departements
Key inclusion criteria (1 listed)
- Admission to hospital blood sample is taken between 24:00 pm till 15:00 pm
Key exclusion criteria (2 listed)
- blood sample is taken after 15:00 pm in the first day of admission during the week
- blood sample is taken on weekend: thursday 15:00 pm till saturday 24:00 pm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immature Platelet Fraction | Other | Critically ill patients admitted to ICU, Neutropinc Fever patients, Patients of Hip's Fracture |
Primary outcome
Time to recovery from sepsis or time to death
Time frame: 6 months
the primary outcome is the result of the patient's admission on which data analysis will be based
1 secondary outcome
Predicting value of IPF for prognosis
Time frame: baeline 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
- Results publication: PubMed 19647322Di Mario A, Garzia M, Leone F, Arcangeli A, Pagano L, Zini G. Immature platelet fraction (IPF) in hospitalized patients with neutrophilia and suspected bacterial infection. J Infect. 2009 Sep;59(3):201-6. doi: 10.1016/j.jinf.2009.07.007. Epub 2009 Jul 18.
- Results publication: PubMed 23093245De Blasi RA, Cardelli P, Costante A, Sandri M, Mercieri M, Arcioni R. Immature platelet fraction in predicting sepsis in critically ill patients. Intensive Care Med. 2013 Apr;39(4):636-43. doi: 10.1007/s00134-012-2725-7. Epub 2012 Oct 24.
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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.
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 Critically Ill Patients and Neutropenic Fever Patients, run by Dr. Yishai Ofran at 1 site in Israel.
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 2 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 20 Dec 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yishai Ofran, Doctor (009720502061524, Y_ofran@ramabm.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery from sepsis or time to death (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02016859, which also lists 2 linked publications.
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 20 Dec 2013.