Berlin PRehospital Or Usual Delivery of Acute Stroke Care

Stroke Clinical Trial

— B_PROUD  

Official title:

Berlin PRehospital Or Usual Delivery of Acute Stroke Care - Functional Outcomes After Advanced Prehospital Stroke Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869386
• Other study ID #: B_PROUD
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: October 24, 2019

Study information

• Verified date: October 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: October 24, 2019
• Est. primary completion date: October 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (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. Symptom remission until arrival of emergency medical service

2. Malignant or other severe primary disease with life expectancy < 1 year

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

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• STEMO
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.
• Regular care
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.

Locations

Country	Name	City	State
Germany	Charite	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Center for Stroke Research Berlin

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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. Review. — View 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. — View 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. — View 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. — View 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, Tütüncü 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptomatic hemorrhage (A)	According to NINDS definition after 36 hours in patients receiving thrombolysis or thrombectomy	3 months
Other	Symptomatic hemorrhage (B)	According to ECASS III definitions after 36 hours in patients receiving thrombolysis or thrombectomy	3 months
Primary	Modified Rankin Scale	Assessment of functional outcome over the entire range of the modified Rankin Scale	3 months
Primary	Co-primary 3-Month Outcome	The co-primary 3-month outcome includes the following range of outcomes: mRS 1-3 if available; mRS 4-5 or (if mRS is missing) living in institution (information according registration office at 4 month after stroke); death.; We will run a sensitivity analysis with the co-primary outcome and calculating all patients with missing mRS but still living under private address as mRS 1-3. The latter will help us to include information of patients still living at home but without mRS follow-up. All outcomes will be calculated with ordinal logistic regression.	3 months
Secondary	Thrombolysis rate		3 months
Secondary	Thrombectomy rate		3 months
Secondary	Diagnosis and treatment times (A)	Onset-to-treatment time	3 months
Secondary	Diagnosis and treatment times (B)	onset-to-reperfusion time (for thrombectomy)	3 months
Secondary	Diagnosis and treatment times (C)	alarm-to-imaging time	3 months
Secondary	Diagnosis and treatment times (D)	alarm-to-treatment time	3 months
Secondary	Diagnosis and treatment times (E)	imaging-to-treatment time	3 months
Secondary	Cost-effectiveness (A)	Additional costs due to implementation and running of STEMO	3 months
Secondary	Cost-effectiveness (B)	duration of hospital stay regarding acute treatment and rehabilitation	3 months
Secondary	Cost-effectiveness (C)	hospital related costs	3 months
Secondary	Cost-effectiveness (D)	costs of long-term care	3 months
Secondary	Cost-effectiveness (E)	Additional costs due to implementation and running of STEMO, duration of hospital stay regarding acute treatment and rehabilitation, hospital related costs, costs of long-term care	3 months
Secondary	Quality of life	Assessment with European Quality of Life - 5 Dimensions (EQ-5D) in yearly intervals over 5 years to follow-up	Up to 5 years
Secondary	Modified Rankin Scale shift analyses	Shift analyses for mRS = 1 at 3 months in patients = 80 years of age living at home without disability and mRS = 2 at 3 months in patients > 80 years of age living at home with help or living in an institution	3 months
Secondary	In-hospital mortality	Frequency of patients dying within the duration of the hospital stay after admission for stroke.	7 days
Secondary	Death rate over time	Deaths over time will be determined and compared between groups using a Kaplan-Meier plot	3 months
Secondary	Discharge status	Including in-hospital mortality among patients not included in the primary study population (patients with intracranial hemorrhages as well as patients receiving thrombolysis in stroke mimics)	3 months
Secondary	Modified Rankin Scale in patients with intracranial hemorrhages	Assessment of functional outcome among patients with intracranial hemorrhages	3 months
Secondary	Rate of emergency medical service deliveries to specialized facilities	Assessment for patients with acute ischemic stroke to hospitals with Stroke Unit, for patients with cerebral artery occlusion (internal carotid artery, M1 or proximal M2 segment of middle cerebral artery) to hospitals with thrombectomy facility, and for patients with intracerebral hemorrhage to hospitals with neurosurgery department.	3 months

External Links

•   Prehospital Thrombolysis: A Manual from Berlin (2013)