Brain Injuries, TraumaticNCT02803112
Pre-hospital and Intra-hospital Temporal Delays in Patients Requiring Emergent Trauma Craniotomy
An observational study of Brain Injuries, Traumatic, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
The investigators aim to retrospectively map the delays in the acute care of traumatic brain injury patients necessitating emergent craniotomies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Emergent craniotomy for traumatic brain injury
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to 2 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Traumatic brain injury patients undergoing an emergent craniotomy at our institution (a tertiary referral academic teaching hospital in Leuven, Belgium).
Who may be able to join
- every patient undergoing 1 of 3 surgical procedures ('removal of epidural hematoma'; 'removal of acute subdural hematoma'; and 'decompressive craniectomy'), performed between February 1, 2010 and January 31, 2016, as recorded in the surgical database of our institution.
Who cannot join
- who had a delayed clinical or radiological deterioration as a surgical indication;
- who did not have traumatic brain injury as the origin of the intracranial abnormalities;
- in whom not all aforementioned temporal or clinical data were readily available from the electronic patient file; and/or
- who were not admitted via our emergency department.
About this study
Official title: Pre-hospital and Intra-hospital Temporal Delays in Patients Requiring Emergent Trauma Craniotomy. A 6-year Retrospective Analysis in a Level 1 Trauma Center
The investigators aim to retrospectively map the delays in the acute care of traumatic brain injury patients necessitating emergent craniotomies.
Read the detailed description
Despite the high incidence of traumatic brain injury (TBI) and the high numbers of emergent craniotomies for TBI performed worldwide, publications reporting on temporal delays in these patients are very scarce. To the best of the investigators' knowledge, there are only 3 publications providing data on the intra-hospital delay and no publications on pre-hospital delay specifically for TBI patients undergoing emergent craniotomies.
The aim of the present study is to retrospectively map delays between the emergency call of the national emergency telephone dispatch to the hospital's medical emergency service (EC) and the surgical skin incision in emergent TBI craniotomies in the investigators' level 1 trauma center and to propose possible measures to improve performance.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Emergent craniotomy for traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergent craniotomy for traumatic brain injuryProcedure or surgery
Emergent craniotomy for traumatic brain injury (either for removal of an epidural hematoma, subdural hematoma, intraparenchymal hematoma or decompressive craniectomy).
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal delay between emergency call and the surgical skin incision.
Temporal delay (in minutes) between emergency call of the national emergency telephone dispatch to the hospital's medical emergency service and the surgical skin incision during the emergent craniotomy for traumatic brain injury.
Measured: From the trauma onset until 24 hours after the trauma onset.
Secondary outcomes (4)
Temporal delay between emergency call and arrival at our emergency department.
Temporal delay (in minutes) between emergency call of the national emergency telephone dispatch to the hospital's medical emergency service and the arrival at the emergency department of our institution.
Measured: From the trauma onset until 24 hours after the trauma onset.
Temporal delay between arrival at our emergency department and acquisition of the first head CT slice.
Temporal delay (in minutes) between the arrival at the emergency department of our institution and the acquisition of the first head CT slice.
Measured: From the trauma onset until 24 hours after the trauma onset.
Temporal delay between acquisition of the first head CT slice and arrival in the operating room.
Temporal delay (in minutes) between the acquisition of the first head CT slice and arrival in the operating room for emergent trauma craniotomy.
Measured: From the trauma onset until 24 hours after the trauma onset.
Glasgow Outcome Scale
Glasgow Outcome Scale, acquired by a telephone questionnaire, at 6 months after the trauma
Measured: 6 months after the trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startFeb 2010
- Primary completionJan 2016
- Study completion2 Aug 2017
Why it stopped: Inactive
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bart Depreitere, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803112
- Sponsor's protocol ID
- S59232
- Status last verified
- Jun 2016
- First submitted
- 6 Jun 2016
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-hospital and Intra-hospital Temporal Delays in Patients Requiring Emergent Trauma Craniotomy. A 6-year Retrospective Analysis in a Level 1 Trauma Center
- ClinicalTrials.gov ID
- NCT02803112
- Acronym / sponsor ID
- S59232
- Conditions
- Brain Injuries, Traumatic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inactive
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 16 Jun 2016 (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.
The investigators aim to retrospectively map the delays in the acute care of traumatic brain injury patients necessitating emergent craniotomies.
Detailed description
Despite the high incidence of traumatic brain injury (TBI) and the high numbers of emergent craniotomies for TBI performed worldwide, publications reporting on temporal delays in these patients are very scarce. To the best of the investigators' knowledge, there are only 3 publications providing data on the intra-hospital delay and no publications on pre-hospital delay specifically for TBI patients undergoing emergent craniotomies.
The aim of the present study is to retrospectively map delays between the emergency call of the national emergency telephone dispatch to the hospital's medical emergency service (EC) and the surgical skin incision in emergent TBI craniotomies in the investigators' level 1 trauma center and to propose possible measures to improve performance.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Traumatic brain injury patients undergoing an emergent craniotomy at our institution (a tertiary referral academic teaching hospital in Leuven, Belgium).
Key inclusion criteria (1 listed)
- every patient undergoing 1 of 3 surgical procedures ('removal of epidural hematoma'; 'removal of acute subdural hematoma'; and 'decompressive craniectomy'), performed between February 1, 2010 and January 31, 2016, as recorded in the surgical database of our institution.
Key exclusion criteria (4 listed)
- who had a delayed clinical or radiological deterioration as a surgical indication;
- who did not have traumatic brain injury as the origin of the intracranial abnormalities;
- in whom not all aforementioned temporal or clinical data were readily available from the electronic patient file; and/or
- who were not admitted via our emergency department.
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 |
|---|---|---|
| Emergent craniotomy for traumatic brain injuryEmergent craniotomy for traumatic brain injury (either for removal of an epidural hematoma, subdural hematoma, intraparenchymal hematoma or decompressive craniectomy). | Procedure or surgery | – |
Primary outcome
Temporal delay between emergency call and the surgical skin incision.
Time frame: From the trauma onset until 24 hours after the trauma onset.
Temporal delay (in minutes) between emergency call of the national emergency telephone dispatch to the hospital's medical emergency service and the surgical skin incision during the emergent craniotomy for traumatic brain injury.
4 secondary outcomes
Temporal delay between emergency call and arrival at our emergency department.
Time frame: From the trauma onset until 24 hours after the trauma onset.
Temporal delay between arrival at our emergency department and acquisition of the first head CT slice.
Time frame: From the trauma onset until 24 hours after the trauma onset.
Temporal delay between acquisition of the first head CT slice and arrival in the operating room.
Time frame: From the trauma onset until 24 hours after the trauma onset.
Glasgow Outcome Scale
Time frame: 6 months after the trauma
Results and safety
The study was stopped early (reason given: Inactive). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- 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. This study is not recruiting at the moment.
Bart Depreitere, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by Universitaire Ziekenhuizen KU Leuven.
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 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: stopped early, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 stopped early (reason given: Inactive). Results are not available in the source record.
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?
Temporal delay between emergency call and the surgical skin incision. (time frame: From the trauma onset until 24 hours after the trauma onset.). 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 10 Jul 2024.