Cost-effectiveness analyses and LOng Term follow-up in patients randomised in a Multicenter Randomized CLinical trial of Endovascular treatment for Acute ischemic stroke in The Netherlands

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24159

Enrollment

500

Registered

2015-02-26

Start date

2010-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endovasculartreatment, acute ischemic stroke, randomized controlled trial, cost-effectiveness, long-term follow-up endovasculaire behandeling, acuut herseninfarct, gecontroleerd gerandomiseerd onderzoek, kosteneffectiviteit, lange termijn uitkomsten

Interventions

endovascular treatment consist of arterial catheterization with a microcatheter to the level of occlusion and delivery of a thrombolytic agent and/ or mechanical thrombectomy. Both alteplase and uroki

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA • A clinical diagnosis of acute stroke, with a deficit on the NIH stroke scale of 2 points or more. • CT or MRI scan ruling out intracranial hemorrhage. • Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA, DSA or transcranial Doppler/duplex (TCD). • The possibility to start treatment within 6 hours from onset. • Informed consent given. • Age 18 or over.

Exclusion criteria

Exclusion criteria: GENERAL EXCLUSION CRITERIA • Arterial blood pressure > 185/110 mmHg. • Blood glucose 22.2 mmol/L. • Intravenous treatment with thrombolytic therapy in a dose exceeding 0.9 mg/kg alteplase or 90 mg. • Intravenous treatment with thrombolytic therapy despite contra-indications, i.e. major surgery, gastrointestinal bleeding or urinary tract bleeding within the previous 2 weeks, or arterial puncture at a non-compressible site within the previous 7 days. SPECIFIC EXCLUSION CRITERIA FOR INTENDED MECHANICAL THROMBECTOMY • Laboratory evidence of coagulation abnormalities, i.e. platelet count 50 sec or INR >3.0. SPECIFIC EXCLUSION CRITERIA FOR INTENDED INTRA-ARTERIAL THROMBOLYSIS • Cerebral infarction in the distribution of the relevant occluded artery in the previous 6 weeks. • History of intracerebral hemorrhage. • Severe head injury (contusion) in the previous 4 weeks. • Clinical or laboratory evidence of coagulation abnormalities, i.e. platelet count 50 sec or INR >1.7. Current treatment with oral thrombin antagonists, such as argatroban and dabigatran or treatment with oral selective Factor Xa inhibitors, such as rivaroxaban.

Design outcomes

Primary

Measure	Time frame
1. modified Rankin scale and quality of life at 2 years after randomization 2. costs per patient without poor outcome on the Modified Rankin Scale (mRs) and the costs per quality-adjusted life year (QALY) at 2 years after randomization	—

Secondary

Measure	Time frame
Our secondary objectives regarding the long term clinical outcome include occurrence of recurrent strokes and mortality in both treatment groups	—

Contacts

Public ContactY.B.W.E.M. Roos

Academic Medical Center (AMC), Department of Neurology, H2 P.O. Box 22660.

+31 (0)20 5663842

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)