Ministry of Health proposes update to acute stroke treatment protocol

This information is included in the approval report for the Order approving the National Medical Practice Protocol for the interventional treatment of patients with acute stroke, published today by the Ministry of Health for public consultation.

As part of the Priority Action AP – Acute Stroke, in 2024, a total of 3,161 patients were treated with intravenous thrombolysis, 1,191 with mechanical thrombectomy, and over 180 with aneurysmal subarachnoid hemorrhage. The proportion of patients treated with thrombolysis was 9.5%, while those treated with mechanical thrombectomy accounted for 2.95% of all acute ischemic stroke cases.

To improve patient access to cutting-edge treatments, the Ministry of Health has developed a new national medical practice protocol for acute stroke treatment. It was drafted by experts from the Neurology Commission and the Romanian Society of Neurology, in accordance with the latest international medical guidelines.

One of the key changes in the new protocol is the expansion of therapeutic indications so that more patients can benefit from thrombolysis and thrombectomy, including those whose stroke is detected upon waking. These adjustments align the Romanian protocol with European standards and increase patients’ chances of recovery.

In this context, the Ministry of Health proposes repealing Order No. 17/2019, considering that it no longer reflects current realities and treatment needs. The adoption of the new protocol would represent a significant step in improving stroke patient care and reducing the impact of this condition on Romania’s healthcare system.

Summary of the National Medical Practice Protocol for the Interventional Treatment of Acute Stroke

The main provisions of the new protocol for acute ischemic stroke treatment focus on expanding the therapeutic window and improving access to treatment.

Intravenous Thrombolysis (rtPA):

• Applied to eligible patients within the first 4.5 hours of symptom onset.
• The therapeutic window can be extended up to 9 hours in certain cases, based on imaging criteria.
• Patients with wake-up stroke or unknown onset may receive treatment if they meet specific imaging criteria.

Endovascular Treatment (Mechanical Thrombectomy, Thromboaspiration):

• Indicated for patients with large vessel occlusions.
• Success rate exceeds 85%, compared to 40% for intravenous thrombolysis.
• Can be applied up to 24 hours after stroke onset, depending on imaging evaluation.

Types of Centers:

• Primary Centers – Perform only intravenous thrombolysis.
• Advanced Centers – Provide complete treatment, including mechanical thrombectomy.

Pre-Hospital Phase:

• Implementation of a prioritization system („Stroke Code”).
• Pre-notification of hospitals to reduce intervention time.
• Rapid transport to centers capable of performing specific treatments.

Hospital Phase:

• Rapid assessment through CT and angio-CT.
• Prompt administration of thrombolysis and preparation for mechanical thrombectomy if necessary.
• Intensive post-procedure monitoring.

Other aspects:

• Encouraging the use of AI software for advanced imaging.
• Considering previous antiplatelet/anticoagulant treatment in patient eligibility.
• Recommending constant updates to local protocols based on center resources.

This protocol aligns Romania with international standards, ensuring fair access to state-of-the-art treatments for acute stroke patients.

The full document is available on the Ministry of Health’s website.

References:

• • Ministry of Health, Romania

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