Injury of Cervical SpineNCT01278511
Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital
A study testing Canadian C-Spine rule in people with Injury of Cervical Spine and Cervical Spine Fractures, run by KU Leuven at 1 site in Belgium.
Trial summary
This study is designed to evaluate the safety, level of performance and level of comfort with the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Injury of Cervical Spine, Cervical Spine Fractures
- What is being tested?
- Canadian C-Spine rule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to not given
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alert, stable, adult patients presenting with an acute possible injury to the cervical spine
- Alert: GCS ≥ 14
- Stable:
- systolic blood pressure ≥ 90 mmHg
- respiratory frequency 12 - 20 / min
- adult ≥ 18 years old
Show all 11Show fewer
- Acute: ≤ 4
- Possible injury to the cervical spine:
- posterior neck pain following any mechanism
- no neck pain but visible injury above the clavicles
- no neck pain or visible injury above the clavicles but a mechanism that indicates a cervical spine injury
Who cannot join
- Acute paralysis (quadriplegia, paraplegia)
- Penetrating trauma to the neck
- Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Emergency Department of the University Hospitals, Catholic University Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: A Prospective Pilot Study Validating the Canadian C-Spine Rule in a Pre-hospital Setting
This study is designed to evaluate the safety, level of performance and level of comfort with the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates.
- Conditions
- Injury of Cervical Spine, Cervical Spine Fractures
- Being tested
- Canadian C-Spine rule
- Keywords
- Canadian C-Spine Rule, Prehospital Emergency Care, Cervical Spine Injuries, Cervical Spine Fractures, Emergency Medicine Undergraduates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canadian C-Spine ruleOther
Emergency medicine undergraduates will accompany prehospital emergency crews and apply the Canadian C-Spine rule, though cervical collar will be applicated per current protocol.
| Study group | Role | What they receive |
|---|---|---|
| Canadian C-Spine Rule | Experimental | Not described Receives: Other: Canadian C-Spine rule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Missed cervical spine injuries and fractures
Measured: At the first visit to the emergency department until 30 days after inclusion
Secondary outcomes (2)
Performance of the Canadian c-spine rule
Performance includes rule accuracy
Measured: Analyzed at the end of the pilot study in april 2011
Level of comfort
Level of comfort with the decision of the canadian c-spine rule as this is important for a possible implication in protocol
Measured: Analyzed at the end of the pilot study in april 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
Why it stopped: Not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Cervical SpineStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pieter Jan Van Asbroeck, KU Leuven
- Investigators
- Koen Bronselaer, MD, PhD, Study director, Emergency Department of the University Hospitals, Catholic University LeuvenMarc Sabbe, MD, PhD, Principal investigator, Emergency Department of the University Hospitals, Catholic University LeuvenPieter Jan Van Asbroeck, Drs, Principal investigator, Emergency Department of the University Hospitals, Catholic University Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278511
- Sponsor's protocol ID
- S52940
- Status last verified
- Jan 2016
- First submitted
- 13 Jan 2011
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study Validating the Canadian C-Spine Rule in a Pre-hospital Setting
- ClinicalTrials.gov ID
- NCT01278511
- Acronym / sponsor ID
- S52940
- Conditions
- Injury of Cervical Spine, Cervical Spine Fractures
- Keywords
- Canadian C-Spine Rule, Prehospital Emergency Care, Cervical Spine Injuries, Cervical Spine Fractures, Emergency Medicine Undergraduates
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jan 2011
- First posted
- 19 Jan 2011 (estimated)
- 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.
This study is designed to evaluate the safety, level of performance and level of comfort with the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Canadian C-Spine Rule | Experimental | Other: Canadian C-Spine rule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Alert, stable, adult patients presenting with an acute possible injury to the cervical spine
- Alert: GCS ≥ 14
- Stable:
- Acute: ≤ 4
- Possible injury to the cervical spine:
Key exclusion criteria (4 listed)
- Acute paralysis (quadriplegia, paraplegia)
- Penetrating trauma to the neck
- Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery)
- Pregnancy
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 |
|---|---|---|
| Canadian C-Spine ruleEmergency medicine undergraduates will accompany prehospital emergency crews and apply the Canadian C-Spine rule, though cervical collar will be applicated per current protocol. | Other | Canadian C-Spine Rule |
Primary outcome
Missed cervical spine injuries and fractures
Time frame: At the first visit to the emergency department until 30 days after inclusion
2 secondary outcomes
Performance of the Canadian c-spine rule
Time frame: Analyzed at the end of the pilot study in april 2011
Level of comfort
Time frame: Analyzed at the end of the pilot study in april 2011
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
Related trials for Injury of Cervical Spine
Enrolling by invitation
NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces
Spinal Cord Injuries
Active, not recruitingPhase 2
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma
Recruiting
The Outcome of Injured Cervical Spinal Cord With Uncontrolled Swelling Under Duraplasty
Spine Injury, Cord Injury, Spinal
RecruitingObservational study
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Spine Fracture, Degenerative Disc Disease
Recruiting
Effectiveness of Robot-assisted Upper-limb Exercise in Cervical SCI
Cervical Vertebrae Injury
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.
Koen Bronselaer, MD, PhD study director
Emergency Department of the University Hospitals, Catholic University Leuven
Marc Sabbe, MD, PhD principal investigator
Emergency Department of the University Hospitals, Catholic University Leuven
Pieter Jan Van Asbroeck, Drs principal investigator
Emergency Department of the University Hospitals, Catholic University Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canadian C-Spine rule in people with Injury of Cervical Spine and Cervical Spine Fractures, run by KU Leuven at 1 site in Belgium.
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 11 inclusion and 4 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: withdrawn, as of the sponsor's last update on 27 Jan 2016. 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 Belgium. 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 was withdrawn before enrolling participants, so there are no results.
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?
Missed cervical spine injuries and fractures (time frame: At the first visit to the emergency department until 30 days after inclusion). 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 27 Jan 2016.