Stroke, ComplicationStroke ICUNCT04197830
Evaluation of Acute Post-thrombectomy Complications for Stroke
An observational study of Stroke, Complication and Stroke, Acute, run by University of Liege at 1 site in Belgium.
Trial summary
Retrospective study to assess the incidence of acute complications after thrombectomy for stoke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Complication, Stroke, Acute, Stroke Hemorrhagic
- What is being tested?
- Thrombectomy for stroke
- Type of treatment
- Surgery or procedure
- How many people
- 361 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2020to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective cohort based on a computer medical record.
Who may be able to join
- >18 year old
- ICU admitted patient for stroke and received thrombectomy
Who cannot join
- missing data
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective study to assess the incidence of acute complications after thrombectomy for stoke.
Read the 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.
- Conditions
- Stroke, Complication, Stroke, Acute, Stroke Hemorrhagic
- Being tested
- Thrombectomy for stroke
- Medical subject headings
- Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombectomy for strokeProcedure or surgery
Patients who have had thrombectomy for acute stroke.
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
death during ICU stay
Measured: day 0 to day 5
hemorrhagic complication
hemorrhagic complication base on CT scan at day 1
Measured: day 1
Neurological evaluation
Neurological evaluation based on Glasgow coma scale (from 3 pejorative to 15/15 good)
Measured: day 0 to day 5
Evolution of renal function
Evaluation based on biological analyses : creatinine value based on daily routine blood analysis (in mg/dL).
Measured: day 0 to day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start15 Jan 2020
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Goffin, University of Liege
- Investigators
- Pierre Goffin, MD, MSc, Principal investigator, MontLegia Hospital, Groupe Santé CHC, Liège, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197830
- Sponsor's protocol ID
- 00014
- Acronym
- Stroke ICU
- Status last verified
- Nov 2020
- First submitted
- 9 Dec 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acute Post-thrombectomy Complications for Stroke
- ClinicalTrials.gov ID
- NCT04197830
- Acronym / sponsor ID
- Stroke ICU / 00014
- Conditions
- Stroke, Complication, Stroke, Acute, Stroke Hemorrhagic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective study to assess the incidence of acute complications after thrombectomy for stoke.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective cohort based on a computer medical record.
Key inclusion criteria (2 listed)
- >18 year old
- ICU admitted patient for stroke and received thrombectomy
Key exclusion criteria (1 listed)
- missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombectomy for strokePatients who have had thrombectomy for acute stroke. | Procedure or surgery | – |
Primary outcome
Survival
Time frame: day 0 to day 5
death during ICU stay
hemorrhagic complication
Time frame: day 1
hemorrhagic complication base on CT scan at 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)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Goffin, MD, MSc principal investigator
MontLegia Hospital, Groupe Santé CHC, Liège, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Complication and Stroke, Acute, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: day 0 to day 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.