Bicycle AccidentNCT06819332
Pedal Cycle Related Trauma at the Royal London Hospital
An observational study of Bicycle Accident, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bicycle Accident
- How many people
- 644 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2015to 1 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who attend the Royal London HOSPT
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of Pedal Cycle Related Trauma at the Royal London Hospital
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.
- Conditions
- Bicycle Accident
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiology of bicycle related accidents in London in patients who present to the Royal London Hospital.
Measure epidemiology of bicycle related accidents in London
Measured: 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.
Measured: 6 Weeks (+/-2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Apr 2015
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bicycle AccidentStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 644 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819332
- Sponsor's protocol ID
- 158400
- Status last verified
- Feb 2025
- First submitted
- 19 Apr 2017
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Pedal Cycle Related Trauma at the Royal London Hospital
- ClinicalTrials.gov ID
- NCT06819332
- Acronym / sponsor ID
- 158400
- Conditions
- Bicycle Accident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 644 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who attend the Royal London HOSPT
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiology of bicycle related accidents in London in patients who present to the Royal London Hospital.
Time frame: 14 days
Measure epidemiology of bicycle related accidents in London
1 secondary outcome
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.
Time frame: 6 Weeks (+/-2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bicycle Accident, run by Barts & The London NHS Trust 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 2 inclusion and 5 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 11 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Epidemiology of bicycle related accidents in London in patients who present to the Royal London Hospital. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2025.