Spinal Cord InjuryNCT07015099
Complications Associated With Delayed Admission to Spinal Injury Unit
An observational study of Spinal Cord Injury and Delayed Admission, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to determine the prevalence of complications including PUs at time of admission to a regional spinal injury rehabilitation unit (MCSI), the relationship between wait time to admission for specialist SCI rehabilitation and complication n occurrence, neurological recovery, and length of stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Delayed Admission
- How many people
- 1,400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2025to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Participants will be included if they were 18 years or older at the time of the injury and admitted to MCSI and had an SCI classified by the American Spinal Injury Association Impairment Scale (ASIA) A-D.
Who may be able to join
- All eligible patients will be included, of both sexes.
Who cannot join
- Patients younger than 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
The Robert Jones and Agnes Hunt Orthopaedic Hospital
Oswestry, Sy10 7AG
About this study
Official title: Delayed Transfer to Spinal Injury Unit Post Acute Traumatic Spinal Cord Injury: A Comprehensive Assessment on Health Impacts and Rehabilitation
The aim of this study is to determine the prevalence of complications including PUs at time of admission to a regional spinal injury rehabilitation unit (MCSI), the relationship between wait time to admission for specialist SCI rehabilitation and complication n occurrence, neurological recovery, and length of stay. The hypothesis is that wait time to transfer from the acute hospital to the specialised SCI rehabilitation unit is associated with increased PU prevalence and other SCI complications, as well as poorer neurological recovery and increased length of stay.
Read the detailed description
Pressure ulcers (PUs) are one of many challenging complications in patients with spinal cord injury (SCI). PUs impact on length of rehabilitation, activities of daily living, participation in physical and social activities, health-related quality of life and increases health care costs significantly. Globally, approximately 32% of patients with SCI experience PUs and this may reflect inadequate prevention and management strategies.
Complications including PUs can occur at any time following SCI from the acute phase, the rehabilitation phase and during the long term follow up period, however the highest PU risk is in the acute phase. Older age, decreased general health status and prolonged periods of immobilisation increases risk of PUs in the acute period. Specialised SCI rehabilitation centres are recommended to reduce the overall length of stay (LOS), mortality and reduce complications following SCI.
Variations exist globally between time to admission for specialist rehabilitation from onset of acute traumatic spinal cord injury with averages of 7.3-377 days reported in the literature. Some identified barriers to specialised SCI rehabilitation unit admission include lack of bed availability, shortage of skilled staff, inadequate finance, physical and environmental barriers resulting in increased wait times for specialist rehabilitation. Time to admission to specialist rehabilitation unit greater than one month have been shown to increase the occurrence of complications, including PUs at the time of rehabilitation admission.
A review conducted in 2003 by Bagnall et al., evaluated 22 articles which compared early admission to a specialist SCI unit to late admission and/or no admission. Whilst favourable neurological recovery was suggested for those who were admitted to a specialist centre compared to late or no admission, all the studies included in the review were deemed to be of poor quality, conducted in the 1980/1990s and, in most cases, could not separate the time of referral to an SCI centre to the time of admission.
In 2015, the All Party Parliamentary Group on SCI undertook an inquiry into the impact of nationwide SCI centres and the people they support. They reported that from 118 patients waiting for admission to a SCI unit, contact with an SCI unit on the same day as the injury was only made for 9 patients. The median time from injury to contact with a specialist centre was 6 days and the median time from injury to referral to a SCI centre was 8 days. On further investigation, 36% of cases required additional information before admission suitability, 24% of cases were due to bed availability, 20% of cases were accepted but were later deemed clinically unfit for transfer, 10% were deemed suitable for outreach or out-patient services and the final 10% of cases were deemed 'other'.
However, this is not the case in every part of the UK. In a recent 2023/24 report from The Queen Elizabeth National Spinal Injuries Unit (Glasgow), it was stated that there was no waiting list for admission to the SCI unit for that period, and of those patients referred to the centre, 58% of patients were admitted within one week. It was reported that the mean admission time to the SCI unit was 29 days, compared to the mean admission time for other spinal centres in the UK being 2-3 months.
The effect of delayed admission to a SCI centre for both the individual with injury and the surrounding family can be profound. Not only are patients often in a high state of uncertainty about their possible prognosis but they can also feel extremely overwhelmed by all the unanswered questions. For those who are waiting to be admitted to a SCI unit, a fear of losing their 'window of opportunity', of which may potentially alter their expected functional recovery, can be seen amongst the patients, highlighted in the evidence above. Delayed admission can also lead to a heightened risk of complications such as PUs, contractures and infections, secondary to an increased hospital stay and decreased functional recovery.
An initial service evaluation from January 2016 and December 2018 has been undertaken by clinicians on the MCSI (RJAH) in the last year to begin to investigate the impact of delayed referral to the MCSI on the prevalence of PUs, it found via multivariate analysis that age, sex and wait time to admission for specialist SCI rehabilitation were significant risk factors for the development of PUs. Here it is proposed to build on this study by undertaking a comprehensive analysis using the last decade of data, to evaluate the impact of delayed admission on SCI rehabilitation and neurological recovery.
- Conditions
- Spinal Cord Injury, Delayed Admission
- Keywords
- SCI, Spinal Cord Injury, Delayed admission
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between wait time to admission and complications
Descriptive statistics and hypothesis-testing methods will be used to analyse primary data. Central tendencies (arithmetic mean, median and frequencies) and measures of variability (standard deviation and interquartile ranges) will be obtained. To test the hypothesis of the difference in frequency (sex) and difference in arithmetic means (age), chi-squared test and t-test will be used respectively. Mann-Whitney U-test will be used to test the hypothesis of difference in wait time to transfer for specialist SCI rehabilitation. Multivariable linear and generalised linear regression will be undertaken to identify the potential predictors associated with complication risk, patient recovery and hospital stay from delayed admission to the MCSI rehabilitation centre.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015099
- Sponsor's protocol ID
- RL1 917
- Status last verified
- Jun 2025
- First submitted
- 14 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Transfer to Spinal Injury Unit Post Acute Traumatic Spinal Cord Injury: A Comprehensive Assessment on Health Impacts and Rehabilitation
- ClinicalTrials.gov ID
- NCT07015099
- Acronym / sponsor ID
- RL1 917
- Conditions
- Spinal Cord Injury, Delayed Admission
- Keywords
- SCI, Spinal Cord Injury, Delayed admission
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- Jul 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 11 Jun 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.
The aim of this study is to determine the prevalence of complications including PUs at time of admission to a regional spinal injury rehabilitation unit (MCSI), the relationship between wait time to admission for specialist SCI rehabilitation and complication n occurrence, neurological recovery, and length of stay. The hypothesis is that wait time to transfer from the acute hospital to the specialised SCI rehabilitation unit is associated with increased PU prevalence and other SCI complications, as well as poorer neurological recovery and increased length of stay.
Detailed description
Pressure ulcers (PUs) are one of many challenging complications in patients with spinal cord injury (SCI). PUs impact on length of rehabilitation, activities of daily living, participation in physical and social activities, health-related quality of life and increases health care costs significantly. Globally, approximately 32% of patients with SCI experience PUs and this may reflect inadequate prevention and management strategies.
Complications including PUs can occur at any time following SCI from the acute phase, the rehabilitation phase and during the long term follow up period, however the highest PU risk is in the acute phase. Older age, decreased general health status and prolonged periods of immobilisation increases risk of PUs in the acute period. Specialised SCI rehabilitation centres are recommended to reduce the overall length of stay (LOS), mortality and reduce complications following SCI.
Variations exist globally between time to admission for specialist rehabilitation from onset of acute traumatic spinal cord injury with averages of 7.3-377 days reported in the literature. Some identified barriers to specialised SCI rehabilitation unit admission include lack of bed availability, shortage of skilled staff, inadequate finance, physical and environmental barriers resulting in increased wait times for specialist rehabilitation. Time to admission to specialist rehabilitation unit greater than one month have been shown to increase the occurrence of complications, including PUs at the time of rehabilitation admission.
A review conducted in 2003 by Bagnall et al., evaluated 22 articles which compared early admission to a specialist SCI unit to late admission and/or no admission. Whilst favourable neurological recovery was suggested for those who were admitted to a specialist centre compared to late or no admission, all the studies included in the review were deemed to be of poor quality, conducted in the 1980/1990s and, in most cases, could not separate the time of referral to an SCI centre to the time of admission.
In 2015, the All Party Parliamentary Group on SCI undertook an inquiry into the impact of nationwide SCI centres and the people they support. They reported that from 118 patients waiting for admission to a SCI unit, contact with an SCI unit on the same day as the injury was only made for 9 patients. The median time from injury to contact with a specialist centre was 6 days and the median time from injury to referral to a SCI centre was 8 days. On further investigation, 36% of cases required additional information before admission suitability, 24% of cases were due to bed availability, 20% of cases were accepted but were later deemed clinically unfit for transfer, 10% were deemed suitable for outreach or out-patient services and the final 10% of cases were deemed 'other'.
However, this is not the case in every part of the UK. In a recent 2023/24 report from The Queen Elizabeth National Spinal Injuries Unit (Glasgow), it was stated that there was no waiting list for admission to the SCI unit for that period, and of those patients referred to the centre, 58% of patients were admitted within one week. It was reported that the mean admission time to the SCI unit was 29 days, compared to the mean admission time for other spinal centres in the UK being 2-3 months.
The effect of delayed admission to a SCI centre for both the individual with injury and the surrounding family can be profound. Not only are patients often in a high state of uncertainty about their possible prognosis but they can also feel extremely overwhelmed by all the unanswered questions. For those who are waiting to be admitted to a SCI unit, a fear of losing their 'window of opportunity', of which may potentially alter their expected functional recovery, can be seen amongst the patients, highlighted in the evidence above. Delayed admission can also lead to a heightened risk of complications such as PUs, contractures and infections, secondary to an increased hospital stay and decreased functional recovery.
An initial service evaluation from January 2016 and December 2018 has been undertaken by clinicians on the MCSI (RJAH) in the last year to begin to investigate the impact of delayed referral to the MCSI on the prevalence of PUs, it found via multivariate analysis that age, sex and wait time to admission for specialist SCI rehabilitation were significant risk factors for the development of PUs. Here it is proposed to build on this study by undertaking a comprehensive analysis using the last decade of data, to evaluate the impact of delayed admission on SCI rehabilitation and neurological recovery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be included if they were 18 years or older at the time of the injury and admitted to MCSI and had an SCI classified by the American Spinal Injury Association Impairment Scale (ASIA) A-D.
Key inclusion criteria (1 listed)
- All eligible patients will be included, of both sexes.
Key exclusion criteria (1 listed)
- Patients younger than 18 years
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
Relationship between wait time to admission and complications
Time frame: 7 months
Descriptive statistics and hypothesis-testing methods will be used to analyse primary data. Central tendencies (arithmetic mean, median and frequencies) and measures of variability (standard deviation and interquartile ranges) will be obtained. To test the hypothesis of the difference in frequency (sex) and difference in arithmetic means (age), chi-squared test and t-test will be used respectively. Mann-Whitney U-test will be used to test the hypothesis of difference in wait time to transfer for specialist SCI rehabilitation. Multivariable linear and generalised linear regression will be undertaken to identify the potential predictors associated with complication risk, patient recovery and hospital stay from delayed admission to the MCSI rehabilitation centre.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- 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.
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 Spinal Cord Injury and Delayed Admission, run by Robert Jones and Agnes Hunt Orthopaedic and District 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 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: opening soon, as of the sponsor's last update on 11 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karina Wright (+441691404022, karina.wright1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between wait time to admission and complications (time frame: 7 months). 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 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.