NCT01590121

Brief Summary

Hereditary Haemorrhagic Telangiectasia (HHT) is a condition in which sufferers have abnormal blood vessels which makes them more likely to bleed than other people, particularly in the lungs, which results in low blood oxygen levels. Flying may make this worse and cause problems. The investigators want to know if there are an increased number of problems on flights compared to on land. The investigators currently do not have any evidence based guidelines on air travel to best advice people who suffer with HHT. The investigators would therefore like to ask individuals who have HHT about their experience on a flight, using a postal questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
12.5 years until next milestone

Results Posted

Study results publicly available

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

September 1, 2024

Enrollment Period

1.7 years

First QC Date

April 30, 2012

Results QC Date

September 25, 2023

Last Update Submit

September 2, 2024

Conditions

Keywords

Previous flight by aeroplane

Outcome Measures

Primary Outcomes (1)

  • HHT Patients Who by the Questionnaire Did or Did Not Self Report a Medical Complication During Flight

    Of all patients who were sent the questionnaire, this comparison was limited to those who had taken a flight, either long haul or short haul. Participants were compared as to whether they did or did not suffer a flight complication.

    Patient were asked to report all flights taken up until questionnaire completion aged 18-90 (mean 55)ys. 145 HHT-affected respondents had flown for 18,943 hours over 3,950 flights.

Study Arms (1)

Pateints with hereditary haemorrhagic telangiectasia

Other: Aeroplane flight in the past- no active intervention for studyOther: Questionnaire

Interventions

Aeroplane flight(s) previously taken by study participants

Pateints with hereditary haemorrhagic telangiectasia

Flight by aeroplane (previous)

Pateints with hereditary haemorrhagic telangiectasia

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HHT patients previously assesses at Hammersmith Hospital, England

You may qualify if:

  • HHT

You may not qualify if:

  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HammersmithHospital, Imperial College Healthcare NHS Trust

London, W12 0NN, United Kingdom

Location

Related Publications (1)

  • Mason CG, Shovlin CL. Flight-related complications are infrequent in patients with hereditary haemorrhagic telangiectasia/pulmonary arteriovenous malformations, despite low oxygen saturations and anaemia. Thorax. 2012 Jan;67(1):80-1. doi: 10.1136/thoraxjnl-2011-201027. Epub 2011 Sep 26.

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesTelangiectasisHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Dr. Claire Shovlin, Principal Investigator
Organization
Imperial College London

Study Officials

  • Claire L Shovlin, PhD MA MB BChir FRCP

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 2, 2012

Study Start

January 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 12, 2024

Results First Posted

November 12, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations