ClinicalTrials.gg
CompletedNCT06819332Updated Feb 11, 2025

Pedal Cycle Related Trauma at the Royal London Hospital

An observational study in Bicycle Accident, sponsored by Barts & The London NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Barts & The London NHS Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
644
Ages
16 Years and older
Sex
All
01

Study summary

Bespoke is an observational, prospective, cohort study. The aim of this study is to explore injury patterns of patients who require admission to the Royal London Hospital (RLH) Emergency Department (ED)or outpatient clinics as a result of any collision involving a bicycle. Secondary objectives are to determine the circumstances around cycling injury and to explore the effect of cycling collisions on the return to work, activities of daily living and cycling. All patients that attend the Emergency Department of the Royal London Hospital following an injury sustained while cycling, will be invited to take part in the study. Participants will be asked to answer a questionnaire about their cycling routines as well as provide information about the location, conditions and events surrounding their collision. Patients' recovery will be followed by the study team using the electronic health record and by reviewing the patients' notes. Morbidity and mortality data will be completed at death, discharge or 28 days from admission (whichever comes first). The patients will be followed up in person, email, or via telephone at 6 weeks following their initial admission. The research team hosted a Patient and Public Involvement (PPI) event, to determine which outcome measures were important for the public to investigate. It was found that the majority of the group felt it was important to follow up return to work, return to cycling and return to activities of daily living in any patients who have had a cycling collision. These outcomes will be measured at the 6 week follow up.

02

Conditions studied

  • Bicycle Accident
03

In context

Lead sponsor

Barts & The London NHS Trust is the lead sponsor of 151 studies on the registry; 21 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who attend the Royal London HOSPT

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients who are 16 years and older attending the Royal London Hospital Emergency department who have been injured while riding a bicycle (pedal cycle)
  • All patients who are 16 years and older who are transferred to the Royal London Hospital, either for inpatient or outpatient care, who were injured whilst riding a bicycle

Exclusion criteria

Exclusion Criteria:

  • Patients who have been injured while involved in activities other than cycling
  • Patients that decline to take part in the study
  • Patients who are 15 years or younger
  • Off road cyclists
  • motorbike riders
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
644 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Epidemiology of bicycle related accidents in London in patients who present to the Royal London Hospital.

    Measure epidemiology of bicycle related accidents in London

    Time frame: 14 days

Secondary outcomes

  1. To map collision hotspots in London and quantify and draw patients' quality of life after injury using using EQ-5D - EuroQol as a measuring tool to assess patient generic health status and SF-12 to measure functional health and well-being.

    Using EQ-5D - EuroQol as a measuring tool to assess patient generic health. 5-level EQ-5D version by EuroQol for descriptive and visual analogue scale.

    Time frame: 6 Weeks (+/-2 weeks)

07

Study locations

1 site
  • Royal London Hospital
    London, E1 1BB, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2015 to primary completion in Nov 2017, 31 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 19, 2017
First posted
Feb 11, 2025
StartActual
Apr 1, 2015
Primary completionActual
Nov 1, 2017
CompletionActual
Nov 1, 2017
Last update
Feb 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06819332
Responsible party
Sponsor
First posted
Feb 11, 2025
Start date
Apr 1, 2015
Primary completion
Nov 1, 2017
Completion
Nov 1, 2017
Last update
Feb 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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