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

Charité University Medicine Berlin

Status: Completed

Conditions: Stroke

Treatments: Procedure: STEMO; Procedure: Regular care

Study type: Interventional

Funder types: Other

Identifiers

NCT03931616

B_PROUD 2.0

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,050 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,050 participants in 2 patient groups

STEMO deployment

Experimental group

Description:

STEMOs are specialized stroke ambulances providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support.

Treatment:

Procedure: STEMO

Regular care

Active Comparator group

Description:

Regular prehospital care consists of normal ambulance care. In suspected life-threatening cases, an emergency physician is sent to the emergency scene in parallel.

Treatment:

Procedure: Regular care