"Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas

Acute Stroke Clinical Trial

Official title:

"Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465346
• Other study ID #: USaarland
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: February 2018

Study information

• Verified date: January 2019
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment of acute stroke must be fast. The aim of this trial is to show feasibility, safety and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site for hyperacute treatment and transfer to the most appropriate target hospital. The effects on reduction delays until different stroke treatments will be assessed. First estimations of cost-effectiveness will also be performed.

Description:

Stroke is a medical emergency for which "time-is-brain". Indeed, a huge body of animal experimental and clinical evidence exists that demonstrates that reducing the time to thrombolytic therapy is the most important variable in prevention of the disability. However, most stroke patients arrive to hospital too late for any type of acute stroke treatment: Only an estimated 19-60% of stroke patients present within 3 hours after symptom onset. Today, for stroke patients 3 different treatment options exist.

1. Thrombolysis with recombinant tissue plasminogen activator (rt-PA) is an effective treatment for many acute stroke patients as evidenced by several large randomized trials.

2. More recently, mechanical clot removal via catheters has been developed. There is currently increasing evidence that in obstruction of large brain vessels such endovascular treatment is superior to systemic thrombolysis in regard to recanalization rates and outcome.

3. Patients with intracranial hemorrhage can profit if transferred to hospitals with neurosurgical treatment options such as ventricular drainage or hematoma removal.

However, each of these treatment are highly time sensitive and due the availability of endovascular and neurosurgical treatment options only in very few highly specialized neurovascular centres decision in which institution the patient should be transported is of high medical and financial relevance. The aim of this trial is to show feasibility, safety and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site and its role in decision regarding transfer to appropriate target institution, thus potentially allowing reduction of time until treatment and delays until specialized treatment also in remote regions. First estimations of cost-effectiveness will also be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Symptoms of acute stroke reported to the EMS dispatcher office (extended FAST Score, Table I) and verified by the EMS (after glucose testing)

• Reported onset of symptoms until call = 8 hours

• Patients with "wake up stroke"

• Age older than 18 years

• Patient (or representative) is willing to participate voluntarily and to sign a written informed consent.

Exclusion Criteria:

• Cardiopulmonary unstable medical conditions requiring immediate treatment in an intensive care unit

• Patients with preexisting severe functional impairment and disease

• Known allergy or contraindications to contrast agents

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Device:
• MSU-based stroke management
Prehospital stroke treatment with a mobile stroke unit
• Control stroke management
Conventional stroke management

Locations

Country	Name	City	State
Germany	Department of Neurology, University Hospital of the Saarland	Homburg/Saar	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Walter S, Kostopoulos P, Haass A, Keller I, Lesmeister M, Schlechtriemen T, Roth C, Papanagiotou P, Grunwald I, Schumacher H, Helwig S, Viera J, Körner H, Alexandrou M, Yilmaz U, Ziegler K, Schmidt K, Dabew R, Kubulus D, Liu Y, Volk T, Kronfeld K, Ruckes — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of stroke patients with accurate decision regarding transfer to the most appropriate target hospital		within 3 month
Secondary	Proportion of patients with large vessel occlusion a) being directly transferred to a neurovascular centre, and b) being evaluated/ treated by an interventionalist		within 3 month
Secondary	Time between symptom onset/alarm and evaluation/treatment by an interventional radiologist in case of large vessel occlusion		within 3 month
Secondary	Proportion of patients with haemorrhage being a) directly transferred to a neurovascular centre, and being b) evaluated/treated by a neurosurgeon.		within 3 month
Secondary	Time between symptom onset/alarm and evaluation/treatment by a neurosurgeon in case of haemorrhage		within 3 month
Secondary	Proportion of patients treated with rt-PA and time between symptom onset/ alarm and start of thrombolysis		within 3 month
Secondary	Functional neurological status (mRS) (D7, D90)		within 3 month
Secondary	Proportion of secondary transfers of stroke patients between primary stroke unit and neurovascular centre in all stroke patients, and in subgroups with ischemic and hemorrhagic stroke		within 3 month