Clinical trial NCT03931616: Berlin PRehospital Or Usual Delivery of Acute Stroke Care 2.0 (B_PROUD 2.0)
Official title: Berlin PRehospital Or Usual Delivery of Acute Stroke Care 2.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
prehospital
telemedicine
thrombolysis
endovascular treatment
functional outcome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Center for Stroke Research Berlin
First posted: 2019-04-30
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: 3 months
measure: Co-primary 3-Month Outcome
timeFrame: 3 months
Secondary outcomes:
measure: Thrombolysis rate
timeFrame: 3 months
measure: Thrombectomy rate
timeFrame: 3 months
measure: Diagnosis and treatment times (D)
timeFrame: 3 months
measure: Diagnosis and treatment times (A)
timeFrame: 3 months
measure: Diagnosis and treatment times (B)
timeFrame: 3 months
measure: Diagnosis and treatment times (C)
timeFrame: 3 months
measure: Diagnosis and treatment times (E)
timeFrame: 3 months
measure: Cost-effectiveness (A)
timeFrame: 3 months
measure: Cost-effectiveness (B)
timeFrame: 3 months
measure: Cost-effectiveness (C)
timeFrame: 3 months
measure: Cost-effectiveness (D)
timeFrame: 3 months
measure: Cost-effectiveness (E)
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Modified Rankin Scale shift analyses
timeFrame: 3 months
measure: In-hospital mortality
timeFrame: 7 days
measure: Death rate over time
timeFrame: 3 months
measure: Discharge status
timeFrame: 3 months
measure: Modified Rankin Scale in patients with intracranial hemorrhages
timeFrame: 3 months
measure: Rate of secondary emergency medical service deliveries to specialized facilities
timeFrame: 3 months
measure: Symptomatic hemorrhage (A)
timeFrame: 3 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité
Study officials:
References:
citation: Ebinger M, Winter B, Wendt M, Weber JE, Waldschmidt C, Rozanski M, Kunz A, Koch P, Kellner PA, Gierhake D, Villringer K, Fiebach JB, Grittner U, Hartmann A, Mackert BM, Endres M, Audebert HJ; STEMO Consortium. Effect of the use of ambulance-based thrombolysis on time to thrombolysis in acute ischemic stroke: a randomized clinical trial. JAMA. 2014 Apr 23-30;311(16):1622-31. doi: 10.1001/jama.2014.2850.
citation: Krebes S, Ebinger M, Baumann AM, Kellner PA, Rozanski M, Doepp F, Sobesky J, Gensecke T, Leidel BA, Malzahn U, Wellwood I, Heuschmann PU, Audebert HJ. Development and validation of a dispatcher identification algorithm for stroke emergencies. Stroke. 2012 Mar;43(3):776-81. doi: 10.1161/STROKEAHA.111.634980. Epub 2012 Jan 5.
citation: Ebinger M, Fiebach JB, Audebert HJ. Mobile computed tomography: prehospital diagnosis and treatment of stroke. Curr Opin Neurol. 2015 Feb;28(1):4-9. doi: 10.1097/WCO.0000000000000165.
citation: Wendt M, Ebinger M, Kunz A, Rozanski M, Waldschmidt C, Weber JE, Winter B, Koch PM, Freitag E, Reich J, Schremmer D, Audebert HJ; STEMO Consortium. Improved prehospital triage of patients with stroke in a specialized stroke ambulance: results of the pre-hospital acute neurological therapy and optimization of medical care in stroke study. Stroke. 2015 Mar;46(3):740-5. doi: 10.1161/STROKEAHA.114.008159. Epub 2015 Jan 29.
citation: Kunz A, Ebinger M, Geisler F, Rozanski M, Waldschmidt C, Weber JE, Wendt M, Winter B, Zieschang K, Fiebach JB, Villringer K, Erdur H, Scheitz JF, Tutuncu S, Bollweg K, Grittner U, Kaczmarek S, Endres M, Nolte CH, Audebert HJ. Functional outcomes of pre-hospital thrombolysis in a mobile stroke treatment unit compared with conventional care: an observational registry study. Lancet Neurol. 2016 Sep;15(10):1035-43. doi: 10.1016/S1474-4422(16)30129-6. Epub 2016 Jul 16.
citation: Ebinger M, Harmel P, Nolte CH, Grittner U, Siegerink B, Audebert HJ. Berlin prehospital or usual delivery of acute stroke care - Study protocol. Int J Stroke. 2017 Aug;12(6):653-658. doi: 10.1177/1747493017700152. Epub 2017 Mar 22.
citation: Kunz A, Nolte CH, Erdur H, Fiebach JB, Geisler F, Rozanski M, Scheitz JF, Villringer K, Waldschmidt C, Weber JE, Wendt M, Winter B, Zieschang K, Grittner U, Kaczmarek S, Endres M, Ebinger M, Audebert HJ. Effects of Ultraearly Intravenous Thrombolysis on Outcomes in Ischemic Stroke: The STEMO (Stroke Emergency Mobile) Group. Circulation. 2017 May 2;135(18):1765-1767. doi: 10.1161/CIRCULATIONAHA.117.027693. No abstract available.
citation: Harmel P, Ebinger M, Freitag E, Grittner U, Lorenz-Meyer I, Napierkowski I, Nolte CH, Siegerink B, Audebert HJ. Functional stroke outcomes after mobile stroke unit deployment - the revised protocol for the Berlin Prehospital Or Usual Delivery of acute stroke care (B_PROUD) part 2 study. Neurol Res Pract. 2019 Jun 3;1:18. doi: 10.1186/s42466-019-0022-4. eCollection 2019.