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

Critically Ill Patients Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02016859
• Other study ID #: IPF-2013-Rambam
• Status: Not yet recruiting
• Phase: N/A
• First received: November 10, 2013
• Last updated: December 15, 2013
• Start date: January 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2013
• Source: Rambam Health Care Campus
• Contact: Yishai Ofran, Doctor
• Phone: 009720502061524
• Email: Y_ofran[@]ramabm.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Helsinki Commitee-Rambam Medical Center
• Study type: Observational [Patient Registry]

Clinical 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.

The purpose of the study is to check if the IPF may be used as a prognostic Factor in these patients

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients
• Febrile Neutropenia
• Hip Fractures
• Neutropenic Fever Patients
• Patients With Hip Fractures

Intervention

Other:
• Immature Platelet Fraction

Locations

Country	Name	City	State
Israel	Rambam Health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Yishai Ofran

Country where clinical trial is conducted

Israel, 

References & Publications (2)

De 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	clinical use of IPF as a prognostic factor	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	No
Primary	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	6 months	No
Secondary	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	baeline 6 months	No