Prehospital Advanced Diagnostics and Treatment of Acute Stroke

NCT03158259 | Unknown DMC

• 1 other identifier: 726120
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate the effectiveness of prehospital diagnosis and, when appropriate, of intravenous thrombolytic treatment of ischemic stroke. At the same time, we will take the opportunity to do an explorative study with the aim to further improve the intervention by biomarkers, and outcome measures volumetric measured by MRI images. The intervention study aim to:

• Determine the time from symptom onset to thrombolytic treatment in the Mobila Stroke Unit (MSU) compared to the conventional model
• Determine the number of patients receiving thrombolytic treatment within the 4.5 hrs window in the MSU compared to the conventional model
• Determine if thrombolytic treatment in the MSU, when adjusted for time, results in better mRS- and Barthel outcome compared to treatment in the conventional model The explorative study aim to
• Determine if final IS infarction volume estimated by MRI, is independently correlated with time from symptom onset to thrombolytic treatment
• Define cut-off values for GFAP and RBP4 combined that with sufficient specificity and sensitivity can distinguish ICH from IS
• Determine the influence of time to treatment on pro-inflammatory markers after stroke Hypothesis Intervention study I. The Treat - NASPP MSU model is feasible and reduces onset to treatment time less than 15 min II. The number of patient treated with thrombolysis within 4.5 hrs of symptom onset is significantly increased in the Treat-NASPP MSU model III. Treatment in the Treat-NASPP MSU model does not result in increased day 90 mRS and Barthel as compared to the conventional model when adjusted for time IV. Prehospital thrombolytic treatment of stroke does not increase the risk of secondary cerebral bleeding as compared to in-hospital thrombolytic treatment of stroke (cerebral bleeding worsening within 36 hrs less than 4 per cent, Norsk hjerneslagregister) Explorative study V. The final infarct volume, estimated by MRI, is significantly reduced when thrombolytic treatment is initiated already in the MSU VI. Biomarkers is a valid tool in the hyper acute phase of cerebral illness to exclude contraindication to thrombolysis VII. Reduced onset to treatment time results in lower levels of selected pro-inflammatory molecules

Conditions

Ischemic (Brain) Stroke; Hemorrhagic Stroke; TIA, Brain

Keywords

IS; ICH; rtPa; Prehospital; MSU

Outcome Measures

Primary Outcomes (2)

• Onset to treatment (OTT)

  Time from ictus (stroke/symptomes of stroke) to patient receive appropriate care (thrombolysis when indicated)

  0 - 4.5 hours

• Number of patients treated within 4.5 hours

  The number of patients treated within 4.5 hours

  0 - 4.5 hours

Secondary Outcomes (3)

• mRS and Barthel at day 90 adjusted for OTT time

  90 days after symptom-debut

• Concentration of designated proteins in Ischemic Stroke-patients and patients with Intra Cranial Hemorrhage

  When patient first meets anesthesiologist or paramedic (1 day)

• Infarction volume as measured by MRI

  day 1-3

Study Arms (2)

Intervention group MSU

EXPERIMENTAL

Patient will be diagnosed (NIHSS, CT and conventional blood-measures) and given thrombolytic treatment (when indicated) prehospitally by anesthesiologist in Mobile Stroke Unit (MSU)

Other: Prehospital diagnosis and treatment

Conventional ambulance

ACTIVE COMPARATOR

Patient will be brought to hospital by normal ambulance according to existing procedures. Diagnosis (NIHSS, CT and conventional blood-measures) and thrombolytic treatment (when indicated) will be given in hospital.

Other: Prehospital diagnosis and treatment

Interventions

Prehospital diagnosis and treatment OTHER

The patient will be diagnosed and treated by anesthesiologist in the mobile stroke unit (MSU). The diagnosis will be NIHSS, CT scans by a CT-scanner fitted in the MSU, and blood-analysis in a mobile lab inside the MSU. All performed by a three-person crew consisting of an anesthesiologist, paramedic and nurse-paramedic. The CT images will be sent to the lokal hospital and contact with neurologist in ward established. A decision to treat will be given in collaboration between the neurologist and anesthesiologist.

Conventional ambulance; Intervention group MSU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with suspected stroke met by emergency services within 4 hours after symptom onset Stroke symptoms: sudden weakness of leg or arm, especially on one side, facial asymmetry and/or sudden trouble walking, and speech disturbance (Norwegian Index of medical emergencies 27.03-27.06).

You may not qualify if:

• Age under 18 years Pregnancy Female \< 50 years and uncertainty of pregnancy Uncertainty regarding symptom onset time

Sponsors & Collaborators

• Norwegian Air Ambulance Foundation: lead
• Ostfold Hospital Trust: collaborator
• University of Oslo: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Department of Research and Development, Norwegian Air Ambulance Foundation

Drøbak, 1441, Norway

RECRUITING

Related Publications (4)

• Larsen K, Jaeger HS, Hov MR, Thorsen K, Solyga V, Lund CG, Bache KG. Streamlining Acute Stroke Care by Introducing National Institutes of Health Stroke Scale in the Emergency Medical Services: A Prospective Cohort Study. Stroke. 2022 Jun;53(6):2050-2057. doi: 10.1161/STROKEAHA.121.036084. Epub 2022 Mar 16.

  PMID: 35291821 DERIVED

• Larsen K, Jaeger HS, Tveit LH, Hov MR, Thorsen K, Roislien J, Solyga V, Lund CG, Bache KG. Ultraearly thrombolysis by an anesthesiologist in a mobile stroke unit: A prospective, controlled intervention study. Eur J Neurol. 2021 Aug;28(8):2488-2496. doi: 10.1111/ene.14877. Epub 2021 May 24.

  PMID: 33890385 DERIVED

• Larsen K, Bache KG, Franer E, Tveit LH, Hov MR, Lund CG, Solyga V, Lossius HM. Pre-hospital thrombolysis of ischemic stroke in the emergency service system-A case report from the Treat-NASPP trial. Acta Anaesthesiol Scand. 2019 Mar;63(3):410-413. doi: 10.1111/aas.13285. Epub 2018 Nov 14. No abstract available.

  PMID: 30426474 DERIVED

• Bache KG, Hov MR, Larsen K, Solyga VM, Lund CG. Prehospital Advanced Diagnostics and Treatment of Acute Stroke: Protocol for a Controlled Intervention Study. JMIR Res Protoc. 2018 Feb 28;7(2):e53. doi: 10.2196/resprot.8110.

  PMID: 29490898 DERIVED

MeSH Terms

Conditions

Ischemia; Stroke; Hemorrhagic Stroke; Ischemic Attack, Transient

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Central Study Contacts

Kristi G Bache, PhD

CONTACT

46542271; kristi.bache@norskluftambulanse.no

Christian G Lund, MD PhD

CONTACT

92019415; lundchr@online.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Clinical tests and recordings will not be performed by investigator invested in the study.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective controlled intervention study

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: May 15, 2017
• Primary Completion: March 28, 2020
• Study Completion: March 28, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)