Berlin PRehospital Or Usual Delivery of Acute Stroke Care 2.0 (B_PROUD 2.0)

Charite University, Berlin, Germany1,050 enrolled

Overview

Prehospital stroke care in specialized ambulances increases thrombolysis rates, reduces alarm-to-treatment times, and improves prehospital triage. Preliminary analyses suggest cost-effectiveness. However, scientific proof of improved functional outcome compared to usual care is still lacking. The objective of this trial is to show improved functional outcomes after deployment of a Stroke Emergency Mobile (STEMO) compared to regular care.

This is a pragmatic, prospective, multi-center trial with blinded outcome assessment of treatment candidates three months after stroke. Treatment candidates will be defined as patients with final discharge diagnosis of cerebral ischemia, and onset-to-alarm time ≤4 hours, disabling symptoms not resolved at time of ambulance arrival, and able to walk without assistance prior to emergency. These patients will be included if their emergency call from a predefined catchment area in Berlin, Germany, caused a stroke alarm at the dispatch center during STEMO hours (7am-11pm, Monday-Sunday). About 50% of STEMO dispatches will be handled by regular ambulances since STEMO will be already in operation creating the quasi-randomized control group. Because of several organisational issues during the transition of the STEMO service into provisional regular care, the B\_PROUD 1.0 evaluation has been defined as implementation study and will be complemented by the B\_PROUD 2.0 study. B\_PROUD 2.0. recruits patients with index event after May 1st, 2019. B\_PROUD uses data from the Berlin - SPecific Acute Treatment in ischemic and hemorrhagIc Stroke with longterm outcome (B-SPATIAL) registry. The B-SPATIAL registry started recruitment in January 2016.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,050

Conditions

Stroke

Interventions

STEMOPROCEDURE

STEMO, the intervention, includes prehospital neurological emergency assessment with the option to perform CT and CT-angiography, start specialized treatment at the door-step of the patient's house, including thrombolysis with tissue Plasminogen Activator and blood pressure management (choice of drug at discretion of treating physician), use of telemedicine for image transfer as well as results of point-of-care laboratory, prenotification (e.g. for endovascular treatment), triage and transport.

Regular carePROCEDURE

A regular ambulance, the comparator, not equipped with advanced point-of-care laboratory or CT scanner, without telemedicine and not staffed with a neurologist.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Suspected acute stroke according to the dispatcher stroke identification algorithm during STEMO hours (7am-11pm, Monday-Sunday) and within the STEMO catchment area Inclusion criteria for primary study population: 2. Final diagnosis of ischemic stroke (ICD 10: I63) or TIA (Transient Ischemic Attack, ICD 10: G45 except G45.4) 3. Confirmed onset-to-alarm time ≤ 4 hours at dispatch 4. Pre-stroke modified Rankin scale ≤ 3 (being able to ambulate, in routine clinical care, patients with mRS up to 3 are usually deemed suitable for tissue plasminogen activator treatment) Exclusion Criteria: 1. Remission of disabling symptoms until arrival of emergency medical service 2. Malignant or other severe primary disease with life expectancy \< 1 year Additional exclusion criteria for primary study population: 3. Major surgery within 4 weeks before study inclusion 4. Confirmed stroke within 3 months before study inclusion 5. Absolute contraindications for thrombolysis AND thrombectomy

Locations (1)

Charité

Berlin, Germany

Outcomes

Primary Outcomes

Modified Rankin Scale

Assessment of functional outcome over the entire range of the modified Rankin Scale. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.

Time frame: 3 months

Co-primary 3-Month Outcome

The co-primary 3-month outcome includes the following range of outcomes: 1. mRS 1-3 if available or living at home (information according registration office at 4 month after stroke) 2. mRS 4-5 or (if mRS is missing) living in institution (information according registration office at 4 month after stroke) 3. death. The co-primary outcome will only be used if the mRS follow-up rate remains below 91%. This will help to include valuable information for patients without concrete mRS follow-up information. All outcomes will be calculated with ordinal logistic regression.

Time frame: 3 months

Secondary Outcomes

Thrombolysis rate

Time frame: 3 months

Thrombectomy rate

Time frame: 3 months

Diagnosis and treatment times (D)

alarm-to-treatment time

Time frame: 3 months

Diagnosis and treatment times (A)

Onset-to-treatment time

Time frame: 3 months

Data from ClinicalTrials.gov

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