Organ protection by noble gases - helium therapy in acute ischemic stroke

Phase 2

Completed

• Conditions: cerebral infarct; ischemic stroke; 10007963

• Registration Number: NL-OMON33571
• Lead Sponsor: Gooi-Noord Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

age >= 18 years;
clinical anterior circulation ischemic stroke;
< 12 hours of witnessed symptom onset
National Institutes of Health Stroke Scale (NIHSS) score >= 4;
pre-admission modified Rankin scale (mRS, dutch version) <= 1;
Visual estimation of penumbra/infarct ratio > 20%

Exclusion Criteria

eligible for rt-PA thrombolysis;
inability to obtain written informed consent;
legal incapacity
medically instable (blood pressure >230/120 or <100/60 mmHg, pulse > 120 bpm, mechanical ventilation needed, body temperature above 39*C)
intracerebral hemorrhage on admission non-enhanced CT;
rapidly improving neurological deficits;
pregnancy;
impaired renal function (serum creatinin levels > 130 µmol/l)
allergic to contrast agent;
use of anticoagulation drugs or coagulopathy (PTT > 1.5 times control)
use following nephrotoxic medications: aminoglycosids, amfoterecine B or cisplatin
contra-indication or intolerance to any used substance;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main clinical outcome is the change in neurological deficits between subjects<br /><br>and controls quantified by the National Institute of Health Stroke Scale<br /><br>(NIHSS) at 4 hours. Improvement is defined as a decrease of 4 or more points on<br /><br>the NIHSS.<br /><br><br /><br>For safety analysis, clinical deterioration - defined as a decrease on the<br /><br>Glasgow Coma Scale of more than 2 points and/or a increase of 4 or more points<br /><br>on NIHSS - is primary outcome. </p><br>