NCT06266624

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

2.8 years

First QC Date

January 12, 2024

Last Update Submit

December 5, 2024

Conditions

HHT

Keywords

HHTTourniquet Test

Outcome Measures

Primary Outcomes (1)

  • number of positive Tourniquet Test results in HHT patients

    Documentation of the number of positive Tourniquet Test results in HHT patients

    three years

Study Arms (1)

Tourniquet Test

EXPERIMENTAL

Patients with HHT patients who undergo the Tourniquet Test

Diagnostic Test: Tourniquet Test

Interventions

Tourniquet TestDIAGNOSTIC_TEST

Tourniquet Test was performed in patients with HHT

Tourniquet Test

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Essen

Essen, Nordrhein Westphalen, 45122, Germany

Location

MeSH Terms

Interventions

Capillary Fragility

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2024

First Posted

February 20, 2024

Study Start

September 25, 2020

Primary Completion

July 30, 2023

Study Completion

July 30, 2025

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL

Locations

DE(1)