Hereditary Haemorrhagic Telangiectasia Flight Safety Study

Hereditary Haemorrhagic Telangiectasia Clinical Trial

— Flying and HHT  

Official title:

A Questionnaire Based Study to Evaluate the Safety of Flying in Hereditary Haemorrhagic Telangiectasia (HHT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590121
• Other study ID #: CLS/20
• Status: Completed
• Phase: N/A
• First received: April 30, 2012
• Last updated: May 28, 2015
• Start date: January 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2012
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: NRES
• Study type: Observational

Clinical Trial 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.

Description:

Individuals with Hereditary Haemorrhagic Telangiectasia (HHT) previously reviewed at HHTIC London will be sent an invitation to participate in a short questionnaire study.

Quantitative variables from the questionnaires for statistical analysis will be the number of individuals responding (and number of questionnaires sent out); number of flights taken and number of complications, subgrouped by type, and flight duration in hours. Complication rates will be expressed as proportion of person flight hours.

The quantitative data from the questionnaire will then be compared with quantitative data from patients' medical records using non parametric methods such as Mann Whitney for univariate analyses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

HHT

Exclusion Criteria:

Unable to provide informed consent

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hereditary Haemorrhagic Telangiectasia
• Telangiectasia, Hereditary Hemorrhagic
• Telangiectasis

Intervention

Other:
• Aeroplane flight in the past- no active intervention for study
Aeroplane flight(s) previously taken by study participants
• Questionnaire
Flight by aeroplane (previous)

Locations

Country	Name	City	State
United Kingdom	HammersmithHospital, Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & 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/thoraxjn — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported medical complication		During or in 6 weeks post flight	No