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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50157
Enrollment
97
Registered
2017-03-27
Start date
2018-01-11
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial infarction Heart attack

Interventions

Main trial: No treatment or 1dd 80mg aspirin. Repeated measurements of platelet function testing via venapuncture. Sub-study: No intervention, purely observetional. Repeated measurements of platel

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
PFA-200 parameters: closure time, flow slope, maximum rate of occlusion and area under the curve TBX2 serum levels.

Secondary

MeasureTime frame
Platelet- , reticulated platelet- , leucocyte count and haemoglobin level as a possible effect modifying parameter.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)