- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04197830
Evaluation of Acute Post-thrombectomy Complications for Stroke (Stroke ICU)
November 11, 2020 updated by: Pierre Goffin, University of Liege
Retrospective study to assess the incidence of acute complications after thrombectomy for stoke.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Research in the computerized medical file of patients admitted to intensive care unit (ICU) in the last 5 years for a stroke.
Searching for acute complications during the ICU stay. Looking for hemorrhagic, acute renal failure, hemodynamic support, neurologic degradation.
Study Type
Observational
Enrollment (Actual)
361
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Liège, Belgium, 4000
- MontLegia Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Retrospective cohort based on a computer medical record.
Description
Inclusion Criteria:
- >18 year old
- ICU admitted patient for stroke and received thrombectomy
Exclusion Criteria:
- missing data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival
Time Frame: day 0 to day 5
|
death during ICU stay
|
day 0 to day 5
|
|
hemorrhagic complication
Time Frame: day 1
|
hemorrhagic complication base on CT scan at day 1
|
day 1
|
|
Neurological evaluation
Time Frame: day 0 to day 5
|
Neurological evaluation based on Glasgow coma scale (from 3 pejorative to 15/15 good)
|
day 0 to day 5
|
|
Evolution of renal function
Time Frame: day 0 to day 5
|
Evaluation based on biological analyses : creatinine value based on daily routine blood analysis (in mg/dL).
|
day 0 to day 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pierre Goffin, MD, MSc, MontLegia Hospital, Groupe Santé CHC, Liège, Belgium
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2020
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
March 31, 2020
Study Registration Dates
First Submitted
December 9, 2019
First Submitted That Met QC Criteria
December 12, 2019
First Posted (Actual)
December 13, 2019
Study Record Updates
Last Update Posted (Actual)
November 13, 2020
Last Update Submitted That Met QC Criteria
November 11, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is not a plan to make IPD available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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