ThrombolysisNCT02576379
The Impact of a Helicopter Emergency Medical System on Prognosis in Stroke Patients
An observational study of Thrombolysis, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Stroke is a leading cause of death and disability, and 15 million people suffer a stroke each year; one-third die and one-third are left permanently disabled. Because the risk of stroke increases with age, it has been considered a disease of the elderly, but stroke also occurs in middle-aged people. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombolysis
- How many people
- 1,068 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to May 2015
- How long will I take part?
- 2 Years
- 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: All patients arriving at the regional stroke unit at Copenhagen University Hospital, Roskilde, suspected of an acute vascular condition within the geographical area covered by both HEMS and GEMS in a 40-month period from January 1st 2010 until April 30th 2013. The geographical catchment area is defined as the area from where HEMS transported patients the first year of implementation. We compare stroke patients transported by HEMS with stroke patients transported by GEMS.
Who may be able to join
- All patients arriving at the regional stroke unit at Copenhagen University Hospital, Roskilde, suspected of an acute vascular condition within the geographical area covered by both HEMS and GEMS in a 40-month period from January 1st 2010 until April 30th 2013.
Who cannot join
- For patients with multiple contacts; only the first contact is included in the data for analysis.
About this study
Stroke is a leading cause of death and disability, and 15 million people suffer a stroke each year; one-third die and one-third are left permanently disabled. Because the risk of stroke increases with age, it has been considered a disease of the elderly, but stroke also occurs in middle-aged people.
Thrombolysis with tissue plasminogen activator (tPA) is the preferred choice of reperfusion therapy of ischemic stroke if performed within 4.5 hours from symptom onset. Time to thrombolysis is associated with improved outcome: the sooner the treatment, the less risk of serious - and possibly permanent - damage to the brain. Unfortunately, only a small fraction of stroke patients make it to thrombolysis within the 4.5-hour; one explanation may be system delays including prolonged transportation.
In May 2010, the first physician-staffed Helicopter Emergency Medical Service (HEMS) was implemented in the Eastern part of Denmark. An observational study evaluating the short-term effects of HEMS implementation compared patients transported by conventional ground ambulance (Ground Emergency Medical Service (GEMS)) to patients transported by HEMS. Patients transported by helicopter had increased time to specialized care. However, both 30-day and 1-year mortality was slightly lower in patients transported by HEMS, although not significant, as was the degree of disability at three months measured by the modified Rankin Scale (mRS).
- Conditions
- Thrombolysis
- Keywords
- Helicopter Emergency Medical System, Mortality, Labour market affiliation, Modified Rankin Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HEMS patients | Patients suspected of suffering from a vascular condition within the geographical area covered by both HEMS and GEMS, and were transported by Helicopter Emergency Medical System (HEMS) to the regional stroke unit at Copenhagen University Hospital Roskilde in a 36-month period from May 1st 2010 until April 30th 2013. | |
| GEMS patients | Patients suspected of suffering from a vascular condition within the geographical area covered by both HEMS and GEMS, and were transported by Ground Emergency Medical System (GEMS) to the regional stroke unit at Copenhagen University Hospital Roskilde in a 40-month period from January 1st 2010 until April 30th 2013. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of death during follow-up
Mortality during the follow-up period will be analysed for differences between GEMS and HEMS. Follow-up period is until May 1st 2015. Because of varying access to information on covariates depending on the diagnosis and treatment of the patient, we conduct the analysis as follows: 1) the whole study population; adjusted for sex and age, 2) patients who were suspected of suffering from a vascular condition; adjusted for sex, age and comorbidity (defined as one of the following conditions; diabetes, atrial fibrillation, hypertension, previous myocardial infarction, and previous stroke), and 3) patients who underwent thrombolysis; adjustment for sex, age, comorbidity, and initial National Institutes of Health Stroke Scale (NIHSS) score.
Measured: 2 - 5.5 years after admission to the stroke unit.
Secondary outcomes (5)
The risk of death at 30 day.
Patients are divided into the same three sub-groups and adjusted for the same potential confounders as described in the primary outcome analysis.
Measured: 30 days after admission to the stroke unit.
Modified Rankin Scale (mRS) after three months.
Assessed in patients who underwent thrombolysis.
Measured: Three months
The risk of involuntary early retirement during the follow-up period.
Assessed in all patients suspected of suffering from a vascular condition between 18 and 60 years of age to ensure a sample that was at risk of involuntary early retirement during the full follow-up period.
Measured: 2 - 5.5 years after admission to the stroke unit.
The risk of reduced workability two years after the vascular event
Assessed in all patients suspected of suffering from a vascular condition between 18 and 60 years of age to ensure a sample that was at risk of involuntary early retirement during the full follow-up period.
Measured: Two years after admission to the stroke unit
The percentage of time on social transfer payments during the first two years.
Assessed in all patients suspected of suffering from a vascular condition between 18 and 60 years of age to ensure a sample that was at risk of involuntary early retirement during the full follow-up period.
Measured: Two years after admission to the stroke unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startJan 2010
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ThrombolysisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,068 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamilia S. Funder, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kamilia S. Funder, MD, Principal investigator, Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, RigshospitaletJacob Steinmetz, MD, PhD, Study director, Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576379
- Sponsor's protocol ID
- ALH3-KF-2015
- Status last verified
- Jul 2016
- First submitted
- 13 Oct 2015
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wahlgren N, Ahmed N, Davalos A, Hacke W, Millan M, Muir K, Roine RO, Toni D, Lees KR; SITS investigators. Thrombolysis with alteplase 3-4.5 h after acute ischaemic stroke (SITS-ISTR): an observational study. Lancet. 2008 Oct 11;372(9646):1303-9. doi: 10.1016/S0140-6736(08)61339-2. Epub 2008 Sep 12.
PubMed 18790527Hesselfeldt R, Gyllenborg J, Steinmetz J, Do HQ, Hejselbaek J, Rasmussen LS. Is air transport of stroke patients faster than ground transport? A prospective controlled observational study. Emerg Med J. 2014 Apr;31(4):268-72. doi: 10.1136/emermed-2012-202270. Epub 2013 Feb 6.
PubMed 23389831Funder KS, Rasmussen LS, Lohse N, Hesselfeldt R, Siersma V, Gyllenborg J, Wulffeld S, Hendriksen OM, Lippert FK, Steinmetz J. The impact of a physician-staffed helicopter on outcome in patients admitted to a stroke unit: a prospective observational study. Scand J Trauma Resusc Emerg Med. 2017 Feb 23;25(1):18. doi: 10.1186/s13049-017-0363-3.
PubMed 28231814
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Helicopter Emergency Medical System on Prognosis in Stroke Patients
- ClinicalTrials.gov ID
- NCT02576379
- Acronym / sponsor ID
- ALH3-KF-2015
- Conditions
- Thrombolysis
- Keywords
- Helicopter Emergency Medical System, Mortality, Labour market affiliation, Modified Rankin Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,068 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Oct 2015 (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.
Stroke is a leading cause of death and disability, and 15 million people suffer a stroke each year; one-third die and one-third are left permanently disabled. Because the risk of stroke increases with age, it has been considered a disease of the elderly, but stroke also occurs in middle-aged people.
Thrombolysis with tissue plasminogen activator (tPA) is the preferred choice of reperfusion therapy of ischemic stroke if performed within 4.5 hours from symptom onset. Time to thrombolysis is associated with improved outcome: the sooner the treatment, the less risk of serious - and possibly permanent - damage to the brain. Unfortunately, only a small fraction of stroke patients make it to thrombolysis within the 4.5-hour; one explanation may be system delays including prolonged transportation.
In May 2010, the first physician-staffed Helicopter Emergency Medical Service (HEMS) was implemented in the Eastern part of Denmark. An observational study evaluating the short-term effects of HEMS implementation compared patients transported by conventional ground ambulance (Ground Emergency Medical Service (GEMS)) to patients transported by HEMS. Patients transported by helicopter had increased time to specialized care. However, both 30-day and 1-year mortality was slightly lower in patients transported by HEMS, although not significant, as was the degree of disability at three months measured by the modified Rankin Scale (mRS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEMS patients | – | –Patients suspected of suffering from a vascular condition within the geographical area covered by both HEMS and GEMS, and were transported by Helicopter Emergency Medical System (HEMS) to the regional stroke unit at Copenhagen University Hospital Roskilde in a 36-month period from May 1st 2010 until April 30th 2013. |
| GEMS patients | – | –Patients suspected of suffering from a vascular condition within the geographical area covered by both HEMS and GEMS, and were transported by Ground Emergency Medical System (GEMS) to the regional stroke unit at Copenhagen University Hospital Roskilde in a 40-month period from January 1st 2010 until April 30th 2013. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients arriving at the regional stroke unit at Copenhagen University Hospital, Roskilde, suspected of an acute vascular condition within the geographical area covered by both HEMS and GEMS in a 40-month period from January 1st 2010 until April 30th 2013. The geographical catchment area is defined as the area from where HEMS transported patients the first year of implementation. We compare stroke patients transported by HEMS with stroke patients transported by GEMS.
Key inclusion criteria (1 listed)
- All patients arriving at the regional stroke unit at Copenhagen University Hospital, Roskilde, suspected of an acute vascular condition within the geographical area covered by both HEMS and GEMS in a 40-month period from January 1st 2010 until April 30th 2013.
Key exclusion criteria (1 listed)
- For patients with multiple contacts; only the first contact is included in the data for analysis.
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
Risk of death during follow-up
Time frame: 2 - 5.5 years after admission to the stroke unit.
Mortality during the follow-up period will be analysed for differences between GEMS and HEMS. Follow-up period is until May 1st 2015. Because of varying access to information on covariates depending on the diagnosis and treatment of the patient, we conduct the analysis as follows: 1) the whole study population; adjusted for sex and age, 2) patients who were suspected of suffering from a vascular condition; adjusted for sex, age and comorbidity (defined as one of the following conditions; diabetes, atrial fibrillation, hypertension, previous myocardial infarction, and previous stroke), and 3) patients who underwent thrombolysis; adjustment for sex, age, comorbidity, and initial National Institutes of Health Stroke Scale (NIHSS) score.
5 secondary outcomes
The risk of death at 30 day.
Time frame: 30 days after admission to the stroke unit.
Modified Rankin Scale (mRS) after three months.
Time frame: Three months
The risk of involuntary early retirement during the follow-up period.
Time frame: 2 - 5.5 years after admission to the stroke unit.
The risk of reduced workability two years after the vascular event
Time frame: Two years after admission to the stroke unit
The percentage of time on social transfer payments during the first two years.
Time frame: Two years after admission to the stroke unit
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 Jul 2016.
- Background: PubMed 18790527Wahlgren N, Ahmed N, Davalos A, Hacke W, Millan M, Muir K, Roine RO, Toni D, Lees KR; SITS investigators. Thrombolysis with alteplase 3-4.5 h after acute ischaemic stroke (SITS-ISTR): an observational study. Lancet. 2008 Oct 11;372(9646):1303-9. doi: 10.1016/S0140-6736(08)61339-2. Epub 2008 Sep 12.
- Background: PubMed 23389831Hesselfeldt R, Gyllenborg J, Steinmetz J, Do HQ, Hejselbaek J, Rasmussen LS. Is air transport of stroke patients faster than ground transport? A prospective controlled observational study. Emerg Med J. 2014 Apr;31(4):268-72. doi: 10.1136/emermed-2012-202270. Epub 2013 Feb 6.
- Derived from this study: PubMed 28231814Funder KS, Rasmussen LS, Lohse N, Hesselfeldt R, Siersma V, Gyllenborg J, Wulffeld S, Hendriksen OM, Lippert FK, Steinmetz J. The impact of a physician-staffed helicopter on outcome in patients admitted to a stroke unit: a prospective observational study. Scand J Trauma Resusc Emerg Med. 2017 Feb 23;25(1):18. doi: 10.1186/s13049-017-0363-3.
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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.
Kamilia S. Funder, MD principal investigator
Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
Jacob Steinmetz, MD, PhD study director
Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombolysis, run by Copenhagen University Hospital, Rigshospitalet.
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: finished, as of the sponsor's last update on 11 Jul 2016. 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 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?
Risk of death during follow-up (time frame: 2 - 5.5 years after admission to the stroke unit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02576379, which also lists 3 linked publications.
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 Jul 2016.