Evaluation of platelet activity in patients recovering from a severe infectio
- Conditions
- Hyperaggregability of thrombocytes triggered by severe infection (i.e. pneumonia or invasive urinary tract infection or a cutaneous infection).Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2016-004303-32-NL
- Lead Sponsor
- VU university medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 62
In order to be eligible to participate in the main-trial, a subject must meet all of the following criteria:
Primary clinical diagnosis of pneumonia
OR
Primary clinical diagnosis of invasive urinary tract infection
OR
Primary clinical diagnosis of cutaneous infection
AND
18 years or older on the date of hospital presentation
AND
Hospitalization for at least 24 hours
AND
Having received at least 1 dose of antibiotics within 48 hours of admission.
In order to be eligible to participate in the sub-study, a subject must meet all of the following criteria:
Primary clinical diagnosis of pneumonia
OR
Primary clinical diagnosis of invasive urinary tract infection
OR
Primary clinical diagnosis of cutaneous infection
AND
18 years or older on the date of hospital presentation
AND
Hospitalization for at least 24 hours
AND
Having received at least 1 dose of antibiotics within 48 hours of admission
AND
Known stable cardiovascular disease. Stable cardiovascular disease defined as: coronary artery disease, peripheral vascular disease, or previous myocardial infarction (>12 months).
AND
Known stable cardiovascular disease. Stable cardiovascular disease defined as: coronary artery disease, peripheral vascular disease, or previous myocardial infarction (>12 months).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31
A potential subject who meets any of the following criteria will be excluded from participation in the main-trial:
-Active metastatic cancer (c.q. malignancy)
-Allergy to salicylate
-Platelet count <120*109/l
-History of non-traumatic major bleeding
-Known bleeding diathesis
-Conditions which require antiplatelet therapy
-Usage of antiplatelet therapy
-Surgery 1 month prior to diagnosis
-Currently pregnant
-Chronic usage of medication which are known to influence platelet function other than antibiotics (e.g. NSAID’s, tirofiban, eptifibatide, abciximab, SSRI’s, clomipramine, amitriptyline, dipyridamole, verapamil, diltiazem , ginkgo biloba, ginseng, & St John’s wort)
A potential subject who meets any of the following criteria will be excluded from participation in the sub-study:
-Active metastatic cancer (c.q. malignancy)
-Platelet count <120*109/l
-History of non-traumatic major bleeding
-Known bleeding diathesis
-Surgery 1 month prior to diagnosis
-Currently pregnant
-Chronic usage of medication which are known to influence platelet function other than antibiotics or aspirin (e.g. NSAID’s, tirofiban, eptifibatide, abciximab, SSRI’s, clomipramine, amitriptyline, dipyridamole, verapamil, diltiazem , ginkgo biloba, ginseng, & St John’s wort)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Measuring the efficacy of aspirin in inhibiting platelet activity in patients during (recovery from) a severe infection.;Secondary Objective: •Measuring the ‘natural’ course of platelet activity in patients with<br>a severe infection.<br>•Registry of cardiovascular events within 90 days after the onset of a severe infection.<br>;Primary end point(s): PFA-200 parameters: closure time, flow slope, maximum rate of occlusion and area under the curve<br>TBX2 serum levels. <br>;Timepoint(s) of evaluation of this end point: On three different time frames after the diagnosis of a severe infection:<br>- Day 3 after the first day of the hospitalization (prior to randomization) <br>- Day 14 after the first day of the hospitalizatoin<br>- >Day 90 after the first day of the hospitalizatoin
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Platelet- , reticulated platelet- , leucocyte count and haemoglobin level ;Timepoint(s) of evaluation of this end point: On three different time frames after the diagnosis of a severe infection:<br>- Day 3 after the first day of the hospitalization (prior to randomization) <br>- Day 14 after the first day of the hospitalizatoin<br>- >Day 90 after the first day of the hospitalizatoin