Hereditary Haemorrhagic TelangiectasiaFlying and HHTNCT01590121
Hereditary Haemorrhagic Telangiectasia Flight Safety Study
An observational study of Hereditary Haemorrhagic Telangiectasia, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Hereditary Haemorrhagic Telangiectasia
- What is being tested?
- Aeroplane flight in the past- no active intervention for study and Questionnaire
- How many people
- 156 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Oct 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HHT patients previously assesses at Hammersmith Hospital, England
Who may be able to join
- HHT
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
HammersmithHospital, Imperial College Healthcare NHS Trust
London, W12 0NN
About this study
Official title: A Questionnaire Based Study to Evaluate the Safety of Flying in Hereditary Haemorrhagic Telangiectasia (HHT)
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.
Read the 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.
- Conditions
- Hereditary Haemorrhagic Telangiectasia
- Being tested
- Aeroplane flight in the past- no active intervention for study, Questionnaire
- Keywords
- Previous flight by aeroplane
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aeroplane flight in the past- no active intervention for studyOther
Aeroplane flight(s) previously taken by study participants
QuestionnaireOther
Flight by aeroplane (previous)
| Study group | Role | What they receive |
|---|---|---|
| Pateints with hereditary haemorrhagic telangiectasia | Not described Receives: Other: Aeroplane flight in the past- no active intervention for study; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startJan 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary Haemorrhagic TelangiectasiaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire L Shovlin, PhD MA MB BChir FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590121
- Sponsor's protocol ID
- CLS/20
- Acronym
- Flying and HHT
- Status last verified
- Sep 2024
- First submitted
- 30 Apr 2012
- Last updated
- 12 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21953065
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Questionnaire Based Study to Evaluate the Safety of Flying in Hereditary Haemorrhagic Telangiectasia (HHT)
- ClinicalTrials.gov ID
- NCT01590121
- Acronym / sponsor ID
- Flying and HHT / CLS/20
- Conditions
- Hereditary Haemorrhagic Telangiectasia
- Keywords
- Previous flight by aeroplane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 May 2012 (estimated)
- Results
- Posted 12 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pateints with hereditary haemorrhagic telangiectasia | – | Other: Aeroplane flight in the past- no active intervention for study, Other: Questionnaire |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HHT patients previously assesses at Hammersmith Hospital, England
Key inclusion criteria (1 listed)
- HHT
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aeroplane flight in the past- no active intervention for studyAeroplane flight(s) previously taken by study participants | Other | Pateints with hereditary haemorrhagic telangiectasia |
| QuestionnaireFlight by aeroplane (previous) | Other | Pateints with hereditary haemorrhagic telangiectasia |
Primary outcome
HHT Patients Who by the Questionnaire Did or Did Not Self Report a Medical Complication During Flight
Time frame: 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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21953065Mason 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire L Shovlin, PhD MA MB BChir FRCP principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Haemorrhagic Telangiectasia, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HHT Patients Who by the Questionnaire Did or Did Not Self Report a Medical Complication During Flight (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01590121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.