Prehospital Transcranial Duplex in Patients With Acute St... | NCT01069276

Studies
Prehospital Transcranial Duplex in Patients With Acute Stroke

NCT01069276

Sponsor

Johannes Gutenberg University Mainz

Status

Withdrawn

Last Update Posted

Jun 11, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Stroke

Interventions

No intervention in this study

Countries

Germany

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

ID	Type	Description	Link
6038	Registry Identifier	local ethic comitee

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Changes in preclinical treatment of stroke patients, no more emergency physician will met this patients

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Nov 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 16, 2010

First Submission Date that Met QC Criteria

Feb 16, 2010

First Posted Date

Feb 17, 2010Estimated

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

Jun 9, 2020

Last Update Posted Date

Jun 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim of the study is to investigate patients with acute stroke prehospital with transcranial duplex ultrasound to detect an infarct of the middle cerebral artery.

Detailed Description

The investigation of the patients will be done by an anaesthesiologist who is part of the prehospital medical treatment in Germany. The main question is, wether a non neurologist can detect an infarction of the middle cerebral artery in a short time an lead the patient to the indicated clinic.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with clinical signs of stroke		Patients with clinical signs of stroke	Other: No intervention in this study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention in this study	Other	No intervention in this study	Patients with clinical signs of stroke

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prehospital detection of an infarction of the middle cerebral artery in patients with acute stroke		5 Minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical signs of acute stroke
possibility of TCD

Exclusion Criteria:

acute interventions for vital signs required

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

Patients with clinical signs of acute stroke in the teritorial of the middle cerebral artery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center of the Johannes Gutenberg-University Mainz		Mainz		55131	Germany

Condition Browse Module

MeSH Terms

ID	Term
D020521	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