PHANTOM-S: The Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients - Study "PHANTOM-S"

Completed

Phase 2 Results N/A

Trial Description

The purpose of this prospective study in acute ischemic stroke patients is to compare alarm-to-needle time during randomly allocated periods with and without availability of a specially staffed ambulance equipped with computed tomography (CT) and point-of care diagnostics. The investigators hypothesize that compared to regular care the investigators will reduce alarm-to-needle time by a minimum of 20 minutes by implementation of the stroke emergency mobile unit.

Detailed Description

Time from symptom onset is crucial for the effectiveness of intravenous thrombolysis in acute ischemic stroke patients. Many patients receive tissue Plasminogen Activator (tPA) with considerable delay. The investigators developed an ambulance equipped with a CT-scanner, point-of-care laboratory, teleradiological support and an emergency trained neurologist on board. In the Pre-Hospital Acute Neurological Therapy and Optimization of Medical care in Stroke patients (PHANTOM-S)-study the investigators aim at a reduction of the current alarm-to-needle time by pre-hospital use of tissue Plasminogen Activator in an ambulance.
The investigators hypothesize that compared to regular care we will reduce alarm-to-needle time by a minimum of 20 minutes by implementation of the stroke emergency mobile unit (STEMO).
This is a prospective study comparing randomly allocated periods with and without STEMO availability.

Conditions

Interventions

  • Stroke Emergency Mobile Unit (STEMO) Other
    Other Names: pre-hospital thrombolysis
    Intervention Desc: Patients treated in the STEMO may receive a CT-scan and point-of-care laboratory work up. This depends on the results of the neurological examination including assessment of medical history and the indication for scanning by the radiologist on call. In case of no contraindications patients with acute ischemic stroke will receive intravenous tissue Plasminogen Activator (0.9 mg/kg BW) according to the routine use of tissue Plasminogen Activator in Germany within 4.5 hours of symptom onset but with no formal upper age limit. (In other words, patients older than 80 years will not be excluded.) In case of increased INR and intracerebral hemorrhage patients will receive Prothrombin Complex Concentrate (PCC). All other indications will be treated according to national guidelines or as considered appropriate by the neurologist.
    ARM 1: Kind: Experimental
    Label: Stroke Emergency Unit Mobile (STEMO)
    Description: The STEMO is equipped with a CT-scanner, a point-of-care laboratory and the infrastructure for tele-radiological as well as videoconferencing support. STEMO is operated by a team of experienced neurologists (n=6, half-time positions, with additional formal training in emergency medicine according to the requirements of the Berlin Medical Board), paramedics of the fire brigade (n=3, two years formal training in emergency care) and radiology technicians (n=3, three years formal training in radiology assistance and three months formal training in emergency care).

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary alarm-to-needle time day 1 No
Secondary Functional outcomes three months after symptom onset Yes
Secondary other times day 1 No
Secondary Costs 15 months (coinciding with the anticipated date of the completion of the last follow-up) No
Secondary Proportion of stroke patients receiving tissue Plasminogen Activator (tPA) day 1 No
Secondary Special referral day 1 No
Secondary symptomatic intracerebral hemorrhage 36 hours after symptom onset Yes
Secondary Serious adverse events up to 3 months Yes
Secondary Mortality up to three months Yes
Secondary Costs effectiveness will be assessed 15 months (coinciding with the anticipated date of the completion of the last follow-up) No

Sponsors