Observational Prospective Study of the Predicted Value of Immature Thrombocytes Counts in Three Different Groups of Critically Ill Patients

December 15, 2013 updated by: Dr. Yishai Ofran

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

admmitted patients to multiple departements

Description

Inclusion Criteria:

- Admission to hospital blood sample is taken between 24:00 pm till 15:00 pm

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Critically ill patients admitted to ICU
those patients who are admitted to ICU with multiorgan failure/injury
Other: Immature Platelet Fraction
Neutropinc Fever patients
admitted to ER, haemato-oncology or oncology
Other: Immature Platelet Fraction
Patients of Hip's Fracture
admitted to orthopedic departement
Other: Immature Platelet Fraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predicting value of IPF for prognosis
Time Frame: baeline 6 months
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
baeline 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical use of IPF as a prognostic factor
Time Frame: up to 12 months
this outcome is not uet based we need much more studies in order to be able to use IPF in daily clinical work
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Yishai Ofran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

November 10, 2013

First Submitted That Met QC Criteria

December 15, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

December 20, 2013

Last Update Submitted That Met QC Criteria

December 15, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPF-2013-Rambam

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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