TeleStroke-Guided Thrombolysis for Acute Ischemic Stroke in Oman

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOman Ministry of Health

About this trial

The goal of this study is to establish and examine the efficacy of using a Telestroke network in Oman to facilitate using emergent thrombolysis for patients with acute ischemic stroke encountered in selected peripheral hospitals. It is proposed to establish a TeleStroke network involving two central hospitals in Muscat linked to three to five peripheral hospitals in Oman which currently have access to CT scans and basic infrastructure for management of AIS patients- but do not have a Neurology service. Selected staff from Internal Medicine/Emergency Medicine departments, Nursing, Technical service and support staffs will be trained in the process of assessment and management of AIS patients including the use of IV alteplase or tenecteplase. They will also be trained in timely access of a Neurologist on call at the central hospital(s) using a TeleStroke network. The Neurologist would conduct a Telestroke based clinical assessment of the AIS patient, review imaging and laboratory results in a timely manner and advice the medical team at the peripheral hospital regarding administration of IV alteplase/tenecteplase. The main purpose of such consultation would be to recognize eligible patients for administration of IV thrombolysis safely at the earliest opportunity within 4.5 hours, leading to increased rates of such thrombolysis with expected improved outcomes. Outcomes would be compared among 100 patients with AIS managed across these 5 hospitals prior to initiation of the practice of thrombolysis and at least 100 patients treated each with IV alteplase using TeleStroke Consultation with Neurologist. Demonstration of efficacy of TeleStroke based stroke thrombolysis would lead to effective implementation of this practice in Oman.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • alteplase or tenecteplase

    Drug

    Thrombolysis using TeleStroke consultation with Neurologist

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Thrombolysis armExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

90 day outcome

Clinical outcome on modified Rankin Score at 90 days. This scale rates outcome from 0 to 6, with 0=no symptoms, 5=bed bound requiring assistance, 6=dead.

Time frame
90 days
2

Discharge Outcome

Clinical outcome on modified Rankin Score at discharge from hospital (assessed up to 5 days). This scale rates outcome from 0 to 6, with 0=no symptoms, 5=bed bound requiring assistance, 6=dead.

Time frame
At discharge (assessed up to 5 days)
3

Rate of Thrombolysis

Rate of utilization of IV alteplase / tenecteplase thrombolysis for acute ischemic stroke at peripheral hospitals

Time frame
At admission and initial management- 2 hours

Secondary outcomes

1

Intracranial Hemorrhage Rate

Rate of symptomatic intracranial hemorrhage at 24 hours of IV thrombolysis

Time frame
24 hours
2

Door to Needle time

Time from Triage arrival of patient to time IV thrombolysis is initiated

Time frame
1 hour

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Oman Ministry of Health

Lead sponsor

Sultan Qaboos University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: