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| Name | Class |
|---|---|
| Brahms AG | INDUSTRY |
| NeuroCure Clinical Research Center, Charite, Berlin | OTHER |
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Development of stroke associated pneumonia (SAP) has a detrimental effect on stroke outcome. Biomarker-guided antibiotic treatment of patients at high risk for pneumonia may help to improve stroke outcome. Therefore, the investigators will evaluate whether intensified infection monitoring via Procalcitonin guiding an early standardized antibiotic treatment improves functional outcome after stroke compared with standard therapy based on current guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCT guided arm | Experimental |
| |
| Control | No Intervention | Standard treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor | Device | The physician will be given access to a PCT value for Day 1 - 7. Depending on the PCT concentrations, the protocol recommends or discourages from the use of antibiotics |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin scale (mRS 0-6) score 0-4 adjusted for baseline modified Rankin score | To assess the proportion of patients with a modified Rankin scale (mRS 0-6) score 0-4 at day 90 adjusted for baseline modified Rankin score. | 3 months after onset of symptoms (stroke) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients receiving any antibiotic therapy | To assess the proportion of patients receiving any antibiotic therapy for any duration within 90 days. | 3 months after onset of symptoms (stroke) |
| Modified Rankin scale adjusted for baseline modified Rankin score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Meisel, MD | Charité University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC) | Principal Investigator |
| Stefan Anker, MD PhD | Charité University Berlin (Dept of Cardiology) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC) | Berlin | Germany | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28484421 | Result | Ulm L, Hoffmann S, Nabavi D, Hermans M, Mackert BM, Hamilton F, Schmehl I, Jungehuelsing GJ, Montaner J, Bustamante A, Katan M, Hartmann A, Ebmeyer S, Dinter C, Wiemer JC, Hertel S, Meisel C, Anker SD, Meisel A. The Randomized Controlled STRAWINSKI Trial: Procalcitonin-Guided Antibiotic Therapy after Stroke. Front Neurol. 2017 Apr 24;8:153. doi: 10.3389/fneur.2017.00153. eCollection 2017. | |
| 22925000 |
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|
To assess the Modified Rankin scale at day 90 adjusted for baseline modified Rankin score. |
| 3 months after onset of symptoms (stroke) |
| Barthel Index adjusted for baseline Barthel Index | To assess the Barthel Index (BI 0-100) at day 90 adjusted for baseline Barthel Index. | 3 months after onset of symptoms (stroke) |
| Modified Rankin scale (mRS) score 0-4 adjusted for baseline modified Rankin score | To assess the proportion of patients with a modified Rankin scale (mRS) score 0-4 at day 180 adjusted for baseline modified Rankin score. | 6 months after onset of symptoms (stroke) |
| Modified Rankin scale adjusted for baseline modified Rankin score | To assess the modified Rankin scale at day 180 adjusted for baseline modified Rankin score. | 6 months after onset of symptoms (stroke) |
| Barthel Index adjusted for baseline Barthel Index | To assess the Barthel Index at day 180 adjusted for baseline Barthel Index. | 6 months after onset of symptoms (stroke) |
| Days alive and out of hospital | To assess the days alive and out of hospital at day 90. | 3 months after onset of symptoms (stroke) |
| Time to first event of death, re-hospitalization or recurrent stroke | To assess the time to first event of death, re-hospitalization or recurrent stroke. | within 6 months after onset of symptoms (stroke) |
| Proportion of events of post stroke infections | To assess the proportion of events of post stroke infections to day 7. | within 7 days after onset of symptoms (stroke) |
| Proportion of events of post stroke infection or death | To assess the proportion of events of post stroke infection or death to day 7. | within 7 days after onset of symptoms (stroke) |
| Medium number of days with fever (≥ 37,5°C) per patient | To assess the medium number of days with fever (≥ 37,5°C) per patient to day 7. | within 7 days after onset of symptoms (stroke) |
| Stroke volume analysis | To investigate the effect of an early PCT-guided antiinfective therapy on stroke volume. | 6 months after onset of symptoms (stroke) |
| Length of hospital stay | To assess the length of hospital stay after acute stroke. | on discharge |
| Hospital discharge disposition | To assess the disposition on hospital discharge. | on discharge |
| shift analysis of the mRS |
| Unfallkrankenhaus Berlin Neurologie |
| Berlin |
| Germany |
| Vivantes Auguste Viktoria Klinikum Neurologie | Berlin | Germany |
| Vivantes Neukölln Neurologie | Berlin | Germany |
| Klinikum Frankfurt (Oder) Neurologie | Frankfurt (Oder) | Germany |
| Hospital Vall d'Hebron | Barcelona | Spain |
| Result |
| Ulm L, Ohlraun S, Harms H, Hoffmann S, Klehmet J, Ebmeyer S, Hartmann O, Meisel C, Anker SD, Meisel A. STRoke Adverse outcome is associated WIth NoSocomial Infections (STRAWINSKI): procalcitonin ultrasensitive-guided antibacterial therapy in severe ischaemic stroke patients - rationale and protocol for a randomized controlled trial. Int J Stroke. 2013 Oct;8(7):598-603. doi: 10.1111/j.1747-4949.2012.00858.x. Epub 2012 Aug 28. |
| 32098866 | Result | Hotter B, Hoffmann S, Ulm L, Montaner J, Bustamante A, Meisel C, Meisel A. Inflammatory and stress markers predicting pneumonia, outcome, and etiology in patients with stroke: Biomarkers for predicting pneumonia, functional outcome, and death after stroke. Neurol Neuroimmunol Neuroinflamm. 2020 Feb 25;7(3):e692. doi: 10.1212/NXI.0000000000000692. Print 2020 May. |
| 33280547 | Result | Hotter B, Hoffmann S, Ulm L, Meisel C, Bustamante A, Montaner J, Katan M, Smith CJ, Meisel A. External Validation of Five Scores to Predict Stroke-Associated Pneumonia and the Role of Selected Blood Biomarkers. Stroke. 2021 Jan;52(1):325-330. doi: 10.1161/STROKEAHA.120.031884. Epub 2020 Dec 7. |
| 29202730 | Result | Hotter B, Ulm L, Hoffmann S, Katan M, Montaner J, Bustamante A, Meisel A. Selection bias in clinical stroke trials depending on ability to consent. BMC Neurol. 2017 Dec 4;17(1):206. doi: 10.1186/s12883-017-0989-9. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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