## Protocol Section
### Identification Module
**NCT ID:** NCT02576379

**Brief Title:** The Impact of a Helicopter Emergency Medical System on Prognosis in Stroke Patients

**Official Title:** The Impact of a Helicopter Emergency Medical System on Prognosis in Stroke Patients

#### Organization Study ID Info
**ID:** ALH3-KF-2015
#### Organization
**Class:** OTHER
**Full Name:** Rigshospitalet, Denmark
### Status Module
#### Completion Date
**Date:** 2015-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-07-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-07-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-05

**Type:** ACTUAL

#### Start Date
**Date:** 2010-01

**Status Verified Date:** 2016-07

#### Study First Post Date
**Date:** 2015-10-15
**Type:** ESTIMATED
**Study First Submit Date:** 2015-10-13
**Study First Submit QC Date:** 2015-10-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Rigshospitalet, Denmark

#### Responsible Party

**Investigator Affiliation:** Rigshospitalet, Denmark

**Investigator Full Name:** Kamilia S. Funder

**Investigator Title:** MD.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief 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.

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 Module

**Conditions:**

- Thrombolysis

**Keywords:**

- Helicopter Emergency Medical System

- Mortality

- Labour market affiliation

- Modified Rankin Scale

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1068

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 2 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Label:** HEMS patients

#### Arm Group 2

**Description:** 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.

**Label:** GEMS patients

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Risk of death during follow-up

**Time Frame:** 2 - 5.5 years after admission to the stroke unit.

#### Secondary Outcomes

**Description:** Patients are divided into the same three sub-groups and adjusted for the same potential confounders as described in the primary outcome analysis.

**Measure:** The risk of death at 30 day.

**Time Frame:** 30 days after admission to the stroke unit.

**Description:** Assessed in patients who underwent thrombolysis.

**Measure:** Modified Rankin Scale (mRS) after three months.

**Time Frame:** Three months

**Description:** 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.

**Measure:** The risk of involuntary early retirement during the follow-up period.

**Time Frame:** 2 - 5.5 years after admission to the stroke unit.

**Description:** 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.

**Measure:** The risk of reduced workability two years after the vascular event

**Time Frame:** Two years after admission to the stroke unit

**Description:** 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.

**Measure:** The percentage of time on social transfer payments during the first two years.

**Time Frame:** Two years after admission to the stroke unit

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* For patients with multiple contacts; only the first contact is included in the data for analysis.

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet

**Name:** Kamilia S. Funder, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet

**Name:** Jacob Steinmetz, MD, PhD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** 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.

**PMID:** 18790527

**Citation:** Hesselfeldt 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.

**PMID:** 23389831

**Citation:** Funder 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.

**PMID:** 28231814

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M22306

- Name: Stroke

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004630

- Term: Emergencies

### Misc Info Module

- Version Holder: 2024-05-24
