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Activity of platelets in patients recovering from pneumonia


- candidate number27163
- NTR NumberNTR6425
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mei-2017
- Secondary IDsNL59727.029.16 METC
- Public TitleActivity of platelets in patients recovering from pneumonia
- Scientific TitleASsesment of Platelet function in patients Recovering from severe INfection
- ACRONYMASPIRIN study
- hypothesisAspirin use as primary prevention in hospitalized patients recovering from pneumonia can inhibit platelet activity effectively.
Furthermore, we believe a twice-dosage regimen of aspirin intake might be superior to a once-daily regimen.
- Healt Condition(s) or Problem(s) studiedPneumonia, Platelet reactivity, Aspirin
- Inclusion criteria- Primary diagnosis of pneumonia
- 50 years or older on the date of hospital presentation
- Hospitalization for at least 24 hours, receiving at least 1 dose of antibiotics within 48 hours of admission
- Exclusion criteria- 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
- Chronic usage of anticoagulants (i.e. DOAC's, acenocoumarol) - Surgery 1 month prior to diagnosis
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2017
- planned closingdate1-okt-2019
- Target number of participants102
- InterventionsAspirin intake for 10 days
Group 1: no aspirin intake
Group 2: 80mg aspirin intake in the evening
Group 3: 40mg aspirin intake twice-daily
- Primary outcomePlatelet aggregability, measured by:
- PFA-200 parameters (closure time, flow slope, maximum rate of occlusion, area under the curve)
- TBX2 serum levels
- Secondary outcome- Laboratory endpoints: platelet-, reticulared platelet-, leucocyte count, CRP, BSE, haemoglobin level
- Cardiovascular events
- Timepoints- Day 1-3 since hospitalization (before intervention)
- Day 14 (after intervention)
- Day 90
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Jeske van Diemen
- CONTACT for SCIENTIFIC QUERIES Jeske van Diemen
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Hartstichting
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD2-mei-2017 - 15-sep-2017


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