Tourniquet-Test in HHT | NCT06266624

Studies
Tourniquet-Test in HHT

NCT06266624

Sponsor

University Hospital, Essen

Status

Active, not recruiting

Last Update Posted

Dec 10, 2024Actual

Enrollment

92Actual

Phase

Not Applicable

Conditions

Interventions

Tourniquet Test

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

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2020Actual

Primary Completion Date

Jul 30, 2023Actual

Completion Date

Jul 30, 2025Estimated

First Submitted Date

Jan 12, 2024

First Submission Date that Met QC Criteria

Feb 16, 2024

First Posted Date

Feb 20, 2024Actual

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

Dec 5, 2024

Last Update Posted Date

Dec 10, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Tourniquet test is used as a diagnostic procedure for thrombocytopathies and vascular diseases. Currently, there is no evidence whether this test is also positive in hereditary haemorrhagic telangiectasia (HHT), a vasculopathy. The aim of this study was to investigate whether this non-invasive test could also be used as an additional diagnostic criterion in patients with HHT.

Detailed Description

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tourniquet Test	Experimental	Patients with HHT patients who undergo the Tourniquet Test	Diagnostic Test: Tourniquet Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tourniquet Test	Diagnostic Test	Tourniquet Test was performed in patients with HHT	Tourniquet Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of positive Tourniquet Test results in HHT patients	Documentation of the number of positive Tourniquet Test results in HHT patients	three years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

In patients with confirmed HHT diagnosis (≥ 3 Curaçao criteria or positive molecular genetics)
aged over 18 years

Exclusion Criteria:

if inclusion criteria does not apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Essen		Essen	Nordrhein Westphalen	45122	Germany

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The datasets used and/or analysed during the current study are available from the PI on reasonable request.

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002198	Capillary Fragility

Ancestor Terms

ID	Term
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D002320	Cardiovascular Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided