Last reviewed · How we verify
NCT04156490: OMCAS
Osmotic Agent Use in Middle Cerebral Artery Stroke
trial testing No intervention is planned, this will be a purely retrospective trial. in Ischemic Stroke in 100 participants. Completed in 30 June 2019.
30 June 2019
Quick facts
| Lead sponsor | University of Minnesota |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 10 February 2018 |
| Primary completion | 30 June 2019 |
| Estimated completion | 30 June 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- No intervention is planned, this will be a purely retrospective trial.
Conditions studied
- Ischemic Stroke — all drugs for Ischemic Stroke →
- MCA Infarction — all drugs for MCA Infarction →
Sponsor
University of Minnesota
Who can join
Adults 18 to 80, any sex, with Ischemic Stroke or MCA Infarction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a retrospective chart review of patients that were admitted with large MCA stroke to the Fairview system hospitals between December 2017-December 2018. Patients ischemic stroke volumes will be measured by taking the area of the infarction and multiplying it by the thickness of each CT or MRI slice, the summation of these volumes is the final volume of the ischemic lesion in cubic centimeters. Patients with stroke volumes greater than 70 cc will be included in the study. Patient midline shift will be measured in millimeters at the level of foramen of Monroe anytime during their initial admission and all patients with a shift greater than 1mm will be included. The midline shift will be documented on the first follow-up brain scan (CT or MRI) at least six hours after the initiation of osmotic therapy. Data will be collected from patient charts including: Age, sex, NIHSS on presentation and discharge, history of diabetes mellitus, hypertension, coronary artery disease, atrial fibrillation, and chronic kidney disease. The type of osmotherapy, along with change in serum sodium or osmolality and dose, will also be documented. In patients that did not receive osmotherapy, midline shift will be documented on the first 24-hour scan and every subsequent scan in 24-hour intervals. Death during a hospital stay will also be recorded. The investigators will use the SAS statistical suite to analyze this data.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04156490
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ischemic Stroke
Currently open trials in the same condition.
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- NCT07491952 — Continuous Dual Aspiration Technique With Zoom System for Stroke · recruiting
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Other University of Minnesota trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04156490 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
- Last refreshed: 7 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04156490.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing