Berlin PRehospital Or Usual Delivery of Acute Stroke Care "B_PROUD"

Recruiting

Phase N/A Results N/A

Trial Description

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 the Stroke Emergency Mobile (STEMO) compared to regular care.

Detailed 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, 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 45% of STEMO dispatches will be handled by regular ambulances since STEMO will be already in operation creating the quasi-randomized control group.
B_PROUD uses data from the B-SPATIAL registry. The B-SPATIAL registry has started recruitment in January 2016. However, B_PROUD recruits patients with symptom onset October 1st, 2016 or later (because data access at the dispatch center had to be established first).

Conditions

Interventions

  • STEMO Procedure
    Intervention Desc: 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 telemedicine for further expertise as well as results of point-of-care laboratory, prenotification (e.g. for endovascular treatment), triage and transport.
    ARM 1: Kind: Experimental
    Label: STEMO deployment
    Description: STEMO is a specialized stroke ambulance providing prehospital neurovascular expertise, a CT scanner, point-of-care testing, and telemedical support.
  • Regular care Procedure
    Intervention Desc: A regular ambulance, the comparator intervention, not equipped with advanced point-of-care laboratory or CT scanner, without telemedicine and not staffed with a neurologist.
    ARM 1: Kind: Experimental
    Label: Regular care
    Description: Regular prehospital care consists of an ambulance. In suspected life-threatening cases an emergency physician is sent to the emergency scene in parallel.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale 3 months No
Secondary Thrombolysis rate 3 months No
Secondary Thrombectomy rate 3 months No
Secondary Diagnosis and treatment times (A) 3 months No
Secondary Diagnosis and treatment times (B) 3 months No
Secondary Diagnosis and treatment times (C) 3 months No
Secondary Diagnosis and treatment times (D) 3 months No
Secondary Diagnosis and treatment times (E) 3 months No
Secondary Cost-effectiveness (A) 3 months No
Secondary Cost-effectiveness (B) 3 months No
Secondary Cost-effectiveness (C) 3 months No
Secondary Cost-effectiveness (D) 3 months No
Secondary Cost-effectiveness (E) 3 months No
Secondary Quality of life Up to 5 years No
Secondary Modified Rankin Scale shift analyses 3 months No
Secondary In-hospital mortality 7 days Yes
Secondary Death rate over time 3 months Yes
Secondary Discharge status 3 months No
Secondary Modified Rankin Scale in patients with intracranial hemorrhages 3 months No
Secondary Rate of emergency medical service deliveries to specialized facilities 3 months No

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