Prehospital Advanced Diagnostics and Treatment of Acute Stroke

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

Interventions

OTHER

Prehospital diagnosis and treatment

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.

Sponsors & Collaborators

• Ostfold Hospital Trust

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Norwegian Air Ambulance Foundation

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-15

Primary Completion

2020-03-28

Completion

2020-03-28

Countries

• Norway

Study Locations