No registrations found.
ID
Source
Brief title
Health condition
Helium, ischemic stroke.
helium, ischemische beroerte.
Sponsors and support
Rijksstraatweg 1, 1261 AN Blaricum,
The Netherlands.
Phone: +31 35 539 11 11
Rijksstraatweg 1, 1261 AN Blaricum,
The Netherlands.
Phone: +31 35 539 11 11
Intervention
Outcome measures
Primary outcome
1. 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 outcome
1. 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.
Background summary
In 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.
Study objective
Primary objective: Is 4 hours of inhalation of a gaseous mixture of 79% helium and 21% oxygen feasible and save in acute ischemic stroke?
Study design
T0: 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.
Intervention
Helium breathing trough a mask during 4 hours in the intervention group compared to normal air in control group.
J.R. Kruijk, de
Blaricum 1261 AN
The Netherlands
+31 (0)35 5391111
jdekruijk@tergooziekenhuizen.nl
J.R. Kruijk, de
Blaricum 1261 AN
The Netherlands
+31 (0)35 5391111
jdekruijk@tergooziekenhuizen.nl
Inclusion criteria
1. 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 criteria
1. 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%.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2114 |
| NTR-old | NTR2231 |
| CCMO | NL21743.003.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON33571 |