ASsesment of Platelet function and Inhibition in patients Recovering from severe INfection

Phase 4

Completed

• Conditions: Acute myocardial infarction; Heart attack; 10011082

• Registration Number: NL-OMON50157
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 97

Inclusion Criteria

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
Chronic usage of 80 mg of non-enteric coated acetylsalicylic acid once daily in
the morning.

Exclusion Criteria

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PFA-200 parameters: closure time, flow slope, maximum rate of occlusion and<br /><br>area under the curve<br /><br>TBX2 serum levels. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Platelet- , reticulated platelet- , leucocyte count and haemoglobin level as a<br /><br>possible effect modifying parameter.</p><br>