Trial Outcomes & Findings for Hereditary Haemorrhagic Telangiectasia Flight Safety Study (NCT NCT01590121)

NCT ID: NCT01590121

Last Updated: 2024-11-12

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

156 participants

Primary outcome timeframe

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.

Results posted on

2024-11-12

Participant Flow

Participant milestones

Participant milestones
Measure
Pateints With Hereditary Haemorrhagic Telangiectasia
Aeroplane flight in the past- no active intervention for study: Aeroplane flight(s) previously taken by study participants Questionnaire: Flight by aeroplane (previous)
Overall Study
STARTED
156
Overall Study
COMPLETED
156
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pateints With Hereditary Haemorrhagic Telangiectasia
n=156 Participants
Aeroplane flight in the past- no active intervention for study: Aeroplane flight(s) previously taken by study participants Questionnaire: Flight by aeroplane (previous)
Age, Categorical
<=18 years
0 Participants
n=156 Participants
Age, Categorical
Between 18 and 65 years
103 Participants
n=156 Participants
Age, Categorical
>=65 years
53 Participants
n=156 Participants
Age, Continuous
55 years
n=156 Participants
Sex: Female, Male
Female
96 Participants
n=156 Participants
Sex: Female, Male
Male
60 Participants
n=156 Participants
Region of Enrollment
United Kingdom
156 participants
n=156 Participants

PRIMARY outcome

Timeframe: 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.

Population: Percentage of individuals who reported complications

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.

Outcome measures

Outcome measures
Measure
HHT Flight Group
n=145 Participants
Study participants who self reported by questionnaire that they took one or more flights by aeroplane. We excluded two patients who had flown extensively due to their occupation, reporting over 10,000 flights between them (pilot and cabin crew) as this was a self-selecting group who would substantially skew the data.
HHT Patients Who by the Questionnaire Did or Did Not Self Report a Medical Complication During Flight
77 percentage of patients
Interval 69.6 to 83.5

Adverse Events

Pateints With Hereditary Haemorrhagic Telangiectasia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Claire Shovlin, Principal Investigator

Imperial College London

Phone: +44 208 383 1178

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place