Adjust-Unlikely PE | NCT05708794

Studies
Adjust-Unlikely PE

NCT05708794

Sponsor

Dr. Kerstin de Wit

Status

Completed

Last Update Posted

Feb 12, 2024Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Pulmonary Embolism (Diagnosis)

Interventions

Not provided

Countries

Canada

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

Feb 2024

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

Apr 23, 2023Actual

Primary Completion Date

Sep 8, 2023Actual

Completion Date

Dec 22, 2023Actual

First Submitted Date

Jan 23, 2023

First Submission Date that Met QC Criteria

Jan 23, 2023

First Posted Date

Feb 1, 2023Actual

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

Feb 9, 2024

Last Update Posted Date

Feb 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Kerstin de Wit, Dr. Kerstin de Wit, Associate Professor, Department of Emergency Medicine, Queen's University, Queen's UniversitySponsor-Investigator

Lead Sponsor

Dr. Kerstin de WitOTHER

Collaborators

Name	Class
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of this pilot study is to assess the feasibility of a larger study to determine the Adjust-Unlikely algorithm safety and efficiency for diagnosing PE.

The pilot study objectives are to:

Determine study recruitment rate, per site, per month
Determine study 90-day loss to follow up rate
Estimate of the proportion of enrolled patients who test negative for PE at initial assessment using the Adjust-Unlikely rule
Estimate of the Adjust-Unlikely algorithm efficiency
Compare excluded and missed-eligible patients to study participants: age, sex and prevalence of PE diagnoses at initial testing.

The pilot study hypothesis is that the investigators can recruit at least 20 patients per month and successfully follow at least 90% of patients for 90 days.

Detailed Description

Not provided

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

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of patients who have PE excluded by the Adjust-Unlikely algorithm and who are subsequently diagnosed with either PE or lower limb DVT.		90 days following index presentation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Emergency physician decides to test for PE

Exclusion Criteria:

Tested for PE without using the Adjust-Unlikely algorithm
D-dimer level is known before Adjust-Unlikely assessment
A new indication for anticoagulation on emergency department assessment (other than pulmonary embolism) in a patient not previously prescribed an anticoagulant
Declines participation
Is inaccessible for follow-up
Has previously participated in this study

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 presenting to emergency departments and urgent care centres with symptoms of PE.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kerstin de Wit	Queen's University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kingston Health Sciences Centre		Kingston	Ontario	K7L 2V7	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011655	Pulmonary Embolism
D004194	Disease

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis

Browse Leaves

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Browse Branches

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