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Helium in Ischemic Stroke.


- candidate number7778
- NTR NumberNTR2231
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-feb-2010
- Secondary IDsNL 21743.003.08 / 2008-001737-10 CCMO / EudraCT
- Public TitleHelium in Ischemic Stroke.
- Scientific TitlePilot study of Helium Therapy in Acute Ischemic Stroke.
- ACRONYMHIS
- hypothesisPrimary objective: Is 4 hours of inhalation of a gaseous mixture of 79% helium and 21% oxygen feasible and save in acute ischemic stroke?
- Healt Condition(s) or Problem(s) studiedIschemic stroke, Helium
- Inclusion criteria1. Age >=18 years, not eligible for rt-PA;
2. Clinical anterior circulation ischemic stroke diagnosed by an independent physisian;
3. < 12 hours of witnessed symptom onset;
4. NIHSS >=4;
5. Pre-admission mRS <=1;
6. Visual estimation of penumbra/infarct ratio > 20% on Ct-perfusion;
7. Informed consent.
- Exclusion criteria1. Eligible for rt-PA thrombolysis;
2. Inability to obtain written informed consent;
3. Legal incapacity;
4. Medically unstable (blood pressure > 230/120 or <100/60mmHg, pulse > 120 bpm, body temperature > 39C);
5. Intracerebral haemorrhage on admission non-enhanced CT;
6. Rapidly improving neurological deficits;
7. Pregnancy;
8. Impaired renal function (serum creatinin levels > 130micromol/L);
9. Allergic to contrast agent;
10. Use of anticoagulation drugs or coagulopathy (PTT > 1.5 times control);
11. Use of following nephrotoxic mediactions: aminoglycosids, amfoterine B or cisplatin;
12. Contra-indication or intolerance to any substance;
13. Saturation on admission of < 90%.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-dec-2010
- Target number of participants20
- InterventionsHelium breathing trough a mask during 4 hours in the intervention group compared to normal air in control group.
- Primary outcome1. Main safety endpoint: Clinical deterioration, defined as a decrease on the Glasgow Coma Scale of more than 2 points and/or a decrease of 4 or more points on the NIHSS;
2. Primary clinical endpoint: Comparison of the change in neurological deficits, quantified by the National Institute of Health Stroke Scale (NIHSS) during helium therapy.
- Secondary outcome1. Safety endpoint: Death by any cause and total and specific serious adverse events, including symptomatic heamorrhagic transformation or intracrananial heamorrhage;
2. Secondary clinical endpoints: Neurological deficits at 4 hours, 24 hours, 1 week and at 3 months, quantified on NIHSS and the level of dependency measures on the modified Rankin Scale (mRS) at three months.
- TimepointsT0: Start of helium breathing for 4 hours;
T1= 4 hours: Clinical evaluation using the NIHSS and VAS-sccore;
T2= 24hours: Clinical evaluation using NIHSS;
T3= 1 week: Clinical evluation using NIHSS;
T4= 3 months: Clinical evaluation using NIHSS and mRS.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESMD. PhD. J.R. Kruijk, de
- CONTACT for SCIENTIFIC QUERIESMD. PhD. J.R. Kruijk, de
- Sponsor/Initiator Tergooiziekenhuizen
- Funding
(Source(s) of Monetary or Material Support)
Tergooiziekenhuizen
- PublicationsN/A
- Brief summaryIn the treatment of acute cerebral ischemia the aim is to preserve and salvage the penumbra and to protect the brain from reperfusion injury. Recently, helium was shown to provide neuroprotection in an experimental setting of cerebral ischemia-reperfusion. Substantial evidence of organ protection by noble gases exists in the field of cardioprotection. In the absence of evidence of neuroprotection by helium in human, further investigation is necessary. Our aim is to investigate the safety and feasibility of helium administration in patients with acute ischemic stroke, not eligible for trombolysis.
- Main changes (audit trail)
- RECORD19-feb-2010 - 17-dec-2011


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