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| Name | Class |
|---|---|
| Helgelandssykehuset Hospital Trust | UNKNOWN |
| Nordlandssykehuset Hospital Trust | UNKNOWN |
| Finnmarkssykehuset HF | UNKNOWN |
| UiT The Arctic University of Norway |
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The DIRECT-CT trial is designed to test the hypothesis that remote controlled CT scanning combined with real time audio-and video conference (AVC) guided assessment from an experienced hospital stroke team (tele-stroke) at decentralized medical centers (DMC) reduces time to intravenous thrombolytic treatment compared to the standard pathway.
Intravenous thrombolysis (IVT) treatment is an effective treatment of disabling acute ischemic stroke (AIS) and leads to improved functional outcomes if administered within 4.5 hours after symptom onset. Since the treatment effect is highly time dependent, it is recommended to give IVT as soon as possible after symptom onset to patients with AIS without contraindications. A CT examination of the head must be performed prior to IVT to exclude intracranial hemorrhage. If an intracerebral hemorrhage (ICH) is detected rapid blood pressure lowering medication should be initiated. As of today, timely delivery of acute stroke treatment is challenging in several parts of Norway due to sparsely populated areas with long geographical distances between hospitals. Patients living in rural areas are at risk of not receiving timely acute stroke treatment. Due to the time sensitive nature of IVT, a decentralized approach to diagnostics and treatment is compelling. However, a CT scanner and medical expertise on acute stroke diagnostics and treatment is not readily available in pre-hospital settings in Norway. Investigators therefore plan to 1) assess the feasibility of widespread implementation of a model with decentralized stroke diagnostics and treatment in rural areas with a stationary CT combined with audio-and video guided support from an experienced stroke team at the local hospital 2) compare treatment access, time metrics and outcomes for stroke patients in the DMC catchment area to patients from similar rural areas without access to decentralized diagnostics and treatment. The risk for patients is minimized through remote controlled CT scanning administered from the local hospital combined with tele-stroke guided assessment by an experienced stroke team and regular simulation trainings. All treatment, including thrombolytic therapy, and monitoring routines are performed according to the hospitals' standard operating procedures (SOP). The primary objective is to compare time from Emergency Medical Communication (EMC) notification to IVT treatment between AIS patients in the intervention group comprising patients from geographical areas with an established service of prehospital stroke diagnostics and treatment at the DMC to the control group comprising patients from similar geographical areas undergoing diagnostics and treatment at their local hospital as per standard pathway.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Participants are patients presenting with acute stroke symptoms in rural districts in Norway. A cockpit solution by Syngo Virtual Cockpit® software for remote control of the stationary CT machine at the DMCs from the nearest stroke center is implemented. The EMC center routes the ambulance to DMC Midt-Troms when it is the nearest. A nurse at DMC and the ambulance personnel performs the clinical examination and positions the patient in the CT machine. Through AVC the examination is overseen by the stroke physician, images are interpreted by a radiologist at UNN, and the decision regarding acute treatment is made by the stroke physician at UNN, Tromsø. If indicated, IVT and blood pressure lowering medication is administered by the nurse at the DMC. Patients resenting with acute stroke symptoms in the catchment area of DMC Midt-Troms (Sørreisa and Senja municipalities) and DMC Sør-Helgeland (Brønnøy and Sømna municipalities) comprise the intervention group. |
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| Control | No Intervention | 1) Patients presenting with acute stroke symptoms residing in municipalities in Nord-Troms (Nordreisa, Kåfjord, Skjervøy and Kvænangen) and Nordland (Saltdal, Hamarøy, Steigen and Sørfold) from the time of DMC model implementation until end of study. These patients are from areas that are geographically similar to Midt-Troms and Sør-Helgeland with regards to distance to the nearest hospital, but without access to prehospital CT diagnostics and acute stroke treatment. | |
| Historical control | No Intervention | This control group consists of acute stroke patients from the same municipalities (both intervention and control group) presenting with stroke symptoms within a 5 year period prior to the implementation of prehospital diagnostics and treatment at the DMC. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decentralized diagnostics and treatment | Other | The intervention includes admittance to the DMC for initial diagnostic work up and acute treatment (if indicated). Paramedics examine the patient and assess stroke severity by NIHSS and G-FAST scoring overseen by a stroke physician at the local hospital through real time video conference. A remote controlled CT scan of the head is conducted, and the stroke team at the local hospital evaluates results and makes a treatment decision in real-time AVC. If treatment is indicated, this is administered by local personnel at the DMC before initiating transport to the local hospital or the comprehensive stroke center in case of LVO. Patients who are unable to reach the DMC prior to estimated admission time at their local hospital, will be treated at their local hospital as per standard pathway. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from EMC notification to initiation IVT treatment | The time from Emergency Medical Communication notification to initiation intravenous thrombolysis treatment in eligible patients | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Time from admittance to initiation of IVT treatment (door-to-needle time) | Time from admittance to initiation of IVT treatment (door-to-needle time) in eligible patients | Day 0 |
| Time from admittance to start of blood pressure lowering medication in ICH patients |
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Inclusion Criteria:
- Patients in the catchments areas of the intervention and control group presenting with a clinical suspected diagnosis of stroke within symptom onset within the last 24 hours
Exclusion Criteria:
- Patients presenting with a clinical suspected diagnosis of stroke more than 24 hours after symptom onset
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnethe Eltoft, MD, PhD | Contact | +4797193417 | agnethe.eltoft@unn.no | |
| Eivor Logstein, MD | Contact | Eivor.Logstein@Helgelandssykehuset.no |
| Name | Affiliation | Role |
|---|---|---|
| Tor Ingebrigtsen, MD, PhD | University Hospital of North Norway | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helgelandssykehuset Health Trust | Recruiting | Sandnessjøen | Norway |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2025 | Apr 9, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| OTHER |
| Innlandet Central Hospital HF, Lillehammer | UNKNOWN |
| Oslo University Hospital | OTHER |
| Ringerike hospital HF, Hønefoss Norway | UNKNOWN |
This is a prospective open label, parallel group controlled observational clinical study investigating the effect of a health service innovation. The study assesses the superiority of a model with prehospital remote controlled CT scanning combined with telestroke guided assessment for decentralized diagnostics and acute stroke treatment at the DMCs compared to the standard pathway for stroke patients in rural Norway.
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Time from admittance to start of blood pressure lowering medication in ICH patients patients |
| Day 0 |
| Proportion of AIS patients receiving IVT treatment (y/n) | Proportion of acute ischaemic stroke patients receiving IVT treatment (y/n) | Day 0 |
| Proportion of AIS patients receiving EVT treatment (y/n) | Proportion of acute ischaemic stroke patients receiving endovascular treatment | Day 0 |
| Proportion of patients achieving early neurological improvement | Early neurological improvement, defined as a reduction of ≥8 points on the NHISS, or NIHSS score of 0-1 at 24 hours (22-36 h) (y/n) | Day 1 |
| mRS score at 90 days | functional outcome measured by the modified Rankin Scale score (mRS) at discharge and day 90 (± 2 weeks) • mRS category at day 90 (+/- 2 weeks)
| Month 3 |
| Proportion of patients with symptomatic intracranial hemorrhage (sICH) | Proportion of patients with symptomatic intracranial hemorrhage (sICH) complications defined as intracranial hemorrhage on CT/MRI within 36 hours post IVT causally related to an increase of 4 points or more on the NIHSS (y/n) | Day 1 |
| Time from symptom onset to groin puncture time | Time from symptom onset to groin puncture time in patients undergoing thrombectomy | Day 0 |
| Transportation mode (ground or air ambulance) | Transportation mode to primary or comprehensive stroke centre | Day 0 |
| Mortality | Mortality during hospitalization, 30 days, 90 days and 1 year | Year 1 |
| Final diagnosis | The final discharge diagnosis | Week 2 |
| University Hospital of North Norway Health Trust | Recruiting | Tromsø | Norway |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |