TeleStroke-Guided Thrombolysis for Acute Ischemic Stroke in Oman

Stroke is the second leading cause of death globally and the primary cause of long-term disability. Timely management of acute ischemic stroke (AIS) requires emergent administration of intravenous thrombolytics (alteplase or tenecteplase) within 4.5 hours of symptom onset, often followed by triage for possible thrombectomy. However, many peripheral hospitals, particularly in regions like Oman, lack the specialized neurological expertise necessary for this time-sensitive management.

Telemedicine, specifically 'TeleStroke,' has emerged as a crucial solution in numerous countries and communities to bridge this gap, enabling remote neurological support for acute stroke thrombolysis. The Oman TeleStroke Initiative aims to establish and evaluate the efficacy of such a network.

Study Objectives:

This study aims to:

Establish a TeleStroke 'hub' center within one or two major hospitals in Muscat with existing neurologic services.

Develop 'spoke' TeleStroke centers in five peripheral hospitals (Rustaq, Ibra, Buraimi, Ibri, and Sur) by identifying and engaging multidisciplinary participating teams (Internal Medicine, Emergency Medicine, Imaging, Laboratory, Nursing, Technical support).

Train senior physician-led teams at spoke hospitals in TeleStroke-based acute stroke management protocols, specifically focusing on intravenous thrombolysis.

Educate broader medical and paramedical teams in overall acute stroke management and decision-making processes.

Sequentially initiate acute stroke thrombolysis services at peripheral centers following a stepped-wedge trial model.

Conduct 3-5 mock TeleStroke-based stroke thrombolysis cycles at each peripheral center to ensure readiness and troubleshoot protocols.

Support and monitor 20 stroke care encounters for thrombolysis at each spoke center.

Document demographic data, stroke type and severity (NIH Stroke Scale, GCS), main neurologic deficits, risk factors, discharge outcome (neurologic deficits; NISS; modified Rankin Score), and 3-month outcome for two patient groups at each center: 30 patients receiving conventional management before TeleStroke initiation and 20 patients after TeleStroke-facilitated thrombolysis.

Conduct a comprehensive cost-benefit analysis.

Compare outcomes and cost-benefit between cohorts before and after TeleStroke initiation.

Facilitate handover of the project to a standing committee managed by participating hospitals upon project completion.

Study Design and Setting:

This is an implementation study utilizing a stepped-wedge randomized trial model. The project will establish a TeleStroke network comprising one or two expert 'hub' hospitals in Muscat linked to five 'spoke' hospitals in the periphery (Rustaq, Ibra, Buraimi, Ibri, and Sur). The sequential initiation of thrombolysis services at spoke centers under TeleStroke guidance will allow for observation of conventional management (control phase) followed by the intervention phase at each site.

Intervention and Training:

The intervention involves the implementation of a TeleStroke network and comprehensive training. At peripheral hospitals, 2-3 dedicated senior physicians from Internal Medicine and Emergency Medicine will be trained in acute stroke management, focusing on thrombolytic care. This training will include didactic lectures, case discussions, hands-on sessions (e.g., NIH Stroke Scale administration), CT evaluation in acute stroke, thrombolysis decision-making, post-thrombolysis care, and communication skills. Related medical and paramedical teams (Nursing, Physical Medicine) will also receive training in overall acute stroke and post-stroke patient management. Essential IT infrastructure (computers with audio-video, image/lab upload capabilities) will be provided, and a dedicated computer application for systematic communication and documentation will be adapted. Mock encounters will be practiced at each center to refine protocols and achieve short door-to-needle times.

Key Management Steps:

Eligible patients will undergo a rapid assessment including focused history ("last known to be normal" time), neurological exam (NIHSS, GCS), vital signs, and urgent investigations (blood glucose, CBC, U&E, ECG, CT brain plain, with CTA if available). If eligible for IV alteplase, consent will be obtained, and a TeleStroke consultation with a neurologist will be initiated. The remote neurologist will confirm eligibility, review imaging and labs, confirm consent, recommend the alteplase dose (0.9 mg/kg total, 10% bolus over 2 min, remainder over 1 hour), and guide post-dosing care. Patients will be monitored for BP, sensorium, deficits, and hemorrhage, with repeat CT at 24 hours or earlier if worsening. Patients with poor neurological status or complications may be transferred to a central hospital for expert care. Follow-up will extend to 3 months.

Endpoints of Interest:

Primary Outcomes:

Rate of utilization of IV alteplase thrombolysis for AIS at peripheral hospitals.

3-month clinical outcomes (Good=mRS 0-2; Poor=mRS 3-6) comparing control and rtPA groups.

Rates of intracranial or systemic hemorrhage.

Secondary Outcomes:

Discharge clinical outcomes (Good=mRS 0-2; Poor=mRS 3-6) comparing control and rtPA groups.

Time from patient arrival to initiation of TeleStroke Consult.

Door-to-Needle time for rtPA administration.

Rates of TeleStroke Consultations for acute stroke from peripheral hospitals.

Frequency of patient transfers to central hospitals.

Frequency of ICU admissions required.

Estimated cost of care: Comparison among Controls and rtPA Groups.

Statistical Analysis:

A stepped-wedge randomized model will guide implementation. Data from 30 patients managed conventionally will be documented at each center prior to thrombolysis initiation. After at least 20 thrombolysis encounters per peripheral hospital, overall outcomes will be analyzed. Continuous variables will be summarized using means/SDs or medians/quartiles, and categorical variables using frequencies/percentages. Analyses will be 2-tailed (p<0.05) using SPSS-21. Univariate methods will compare endpoints, and logistic regression will explore factors influencing outcomes. Cost-benefit analysis will compare TeleStroke-based management to conventional methods.

Significance to Oman and Benefits:

This initiative addresses a critical gap in acute ischemic stroke care by extending access to thrombolysis, currently largely inaccessible in many Omani peripheral communities. Successful implementation will align Omani stroke care with current international standards, potentially reducing stroke-related mortality and long-term morbidity. The expected reduction in long-term disability care costs is anticipated to offset program implementation and management expenses. This project will also foster ongoing skilled manpower development in acute care, telemedicine, and TeleStroke technology within Oman. While replicating studies conducted elsewhere, this research is vital to address local limitations such as telecommunications access, technological constraints, and community/hospital acceptability specific to Oman.

Inclusion criteria

• Age >18 years. Acute neurologic deficits due to cerebral ischemia/infarction. Clearly defined onset with duration from stroke onset of <4.5 hours. Significant neurological deficit (usually NIHSS score of 4-25).

Exclusion criteria

• CT brain shows showing evidence of intracranial hemorrhage
• CT brain showing acute or subacute infarct of size about >1/3 Middle Cerebral Artery territory.
• Arterial puncture at non compressible site in previous 7 days
• History of previous intracranial hemorrhage.
• Intracranial neoplasm, AV malformation, or aneurysm
• Recent head injury OR intracranial or intraspinal surgery in last 3 mo.
• Persistent Elevated BP >185/110 mm Hg despite treatment.
• Active ongoing internal bleeding.
• Platelet count <100 000/mm3.
• Current use of NOACs OR warfarin with INR >1.7 OR Inj.Enoxaparin/Heparin in therapeutic dose
• Blood glucose concentration <2.7mmol/L (<50mg/dl).

Relative contraindications: (may consider IV alteplase on individual evaluation).

• Seizure at onset with post ictal residual neurological deficit.
• Signs of mild stroke in isolation or rapidly improving symptoms.
• Pregnancy.
• Recent GI or UT hemorrhage within the last 21 days.
• Recent MI within previous 3 months (to exclude anterolateral infarct / STEMI)