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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02562261
Date of registration:	15/09/2015
Prospective Registration:	No
Primary sponsor:	Charalambos .A. Gogos
Public title:	Platelet REactivity in Sepsis Syndrome (PRESS) PRESS
Scientific title:	Platelet Reactivity During Different Stages of Sepsis
Date of first enrolment:	January 2015
Target sample size:	140
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02562261
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Greece

Contacts

Name:	Charalampos Gogos, MD,PhD
Address:
Telephone:
Email:
Affiliation:	University Hospital of Patras

Name:	Karolina Akinosoglou, MD,PhD
Address:
Telephone:
Email:
Affiliation:	University Hospital of Patras

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients presenting 0-8 hours post admission with signs of one of the following i)
uncomplicated infection/bacteremia ii) sepsis iii) severe sepsis iv) septic shock

- 30 healthy subjects

- Signed informed consent

Exclusion Criteria:

- Pregnancy

- Breastfeeding

- Inability to give informed consent

- PLTs<70.000/ul or PLTs>741.000 ul

- Ht<25% or Ht>52%

- History of P2Y12 or GPIIb/IIIainhibitors the last 15 days prior assortment

- Patients with inherited (vonWillebrand factor deficiency, Glanzmann thrombasthenia,
Bernard-Sulier syndrome) or established acquired platelet disorders (HIT)

- Patients undergoing hemodialysis

- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal
bleeding within the previous 3 months.

- Previous history of immunologic disease (neoplasm, autoimmune disorders, HIV)

- Subjects receiving daily treatment with immune-modulating regimens.

Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sepsis Syndrome

Intervention(s)

Primary Outcome(s)

Comparison of P2Y12 mediated Platelet Reactivity between study groups [Time Frame: at 1 year]

P2Y12 mediated Platelet Reactivity on presentation [Time Frame: 0 hours post presentation]

Secondary Outcome(s)

Repeated measurement of PRU in the same subject when transiting from one group to another [Time Frame: 1 hour to 1 month]

Correlation between serum levels of pro-inflammatory mediators and measured PRU between various study groups [Time Frame: 1 month to 1 year]

Serum levels of pro-inflammatory mediators in various study groups [Time Frame: 1 month to 1 year]

Secondary ID(s)

24958/19-12-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital of Patras

Hellenic Society for Chemotherapy : Hellenic Sepsis Study Group

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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