Hereditary Haemorrhagic Telangiectasia Flight Safety Study (Flying and HHT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01590121
First received: April 30, 2012
Last updated: May 1, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Hereditary Haemorrhagic Telangiectasia
Other: Aeroplane flight in the past- no active intervention for study
Other: Questionnaire

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Questionnaire Based Study to Evaluate the Safety of Flying in Hereditary Haemorrhagic Telangiectasia (HHT)

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Self reported medical complication [ Time Frame: During or in 6 weeks post flight ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pateints with hereditary haemorrhagic telangiectasia Other: Aeroplane flight in the past- no active intervention for study
Aeroplane flight(s) previously taken by study participants
Other: Questionnaire
Flight by aeroplane (previous)

Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HHT patients previously assesses at Hammersmith Hospital, England

Criteria

Inclusion Criteria:

HHT

Exclusion Criteria:

Unable to provide informed consent

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590121

Locations
United Kingdom
HammersmithHospital, Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Claire L Shovlin, PhD MA MB BChir FRCP Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01590121     History of Changes
Other Study ID Numbers: CLS/20
Study First Received: April 30, 2012
Last Updated: May 1, 2012
Health Authority: UK: NRES

Keywords provided by Imperial College London:
Previous flight by aeroplane

Additional relevant MeSH terms:
Telangiectasis
Telangiectasia, Hereditary Hemorrhagic
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 16, 2014