Evaluation of Acute Post-thrombectomy Complications for S... | NCT04197830

Studies
Evaluation of Acute Post-thrombectomy Complications for Stroke

NCT04197830

Sponsor

University of Liege

Status

Completed

Last Update Posted

Nov 13, 2020Actual

Enrollment

361Actual

Phase

Not provided

Conditions

Stroke, Complication
Stroke, Acute
Stroke Hemorrhagic

Interventions

Thrombectomy for stroke

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2020Actual

Primary Completion Date

Mar 31, 2020Actual

Completion Date

Mar 31, 2020Actual

First Submitted Date

Dec 9, 2019

First Submission Date that Met QC Criteria

Dec 12, 2019

First Posted Date

Dec 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2020

Last Update Posted Date

Nov 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

361Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thrombectomy for stroke	Procedure	Patients who have had thrombectomy for acute stroke.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival	death during ICU stay	day 0 to day 5
hemorrhagic complication	hemorrhagic complication base on CT scan at day 1	day 1
Neurological evaluation	Neurological evaluation based on Glasgow coma scale (from 3 pejorative to 15/15 good)	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).	day 0 to day 5

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 year old
ICU admitted patient for stroke and received thrombectomy

Exclusion Criteria:

missing data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Retrospective cohort based on a computer medical record.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Goffin, MD, MSc	MontLegia Hospital, Groupe Santé CHC, Liège, Belgium	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MontLegia Hospital		Liège		4000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

There is not a plan to make IPD available.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D000083302	Hemorrhagic Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017131	Thrombectomy

Ancestor Terms

ID	Term
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided