Penumbral Rescue by Normobaric O=O Administration in Patients with Ischemic Stroke and Target Mismatch ProFile:A Phase II Proof-of-Concept Trial - PROOF

niversitätsklinikum (University Hospital) Tübingen0 sites456 target enrollmentJuly 10, 2018

Overview

No summary available.

Registry

who.int

Start Date

July 10, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversitätsklinikum (University Hospital) Tübingen

•Age: \= 18 years.
•Acute anterior circulation ischemic stroke due to a Large vessel occlusion (LVO) on CT or MR angiography, i.e. either terminal internal carotid artery (ICA) with M1/carotid\-T, proximal M1, distal M1 (distal to perforating branches), or M2/3 segment(s).
•If TBY is likely to be conducted.
•NIHSS score of \= 6 at screening.
•Alberta Stroke Program Early CT score (ASPECTS) of 6\-10 on non\-contrast CT or 5\-10 on diffusion\-weighted MRI (DWI\-MRI)
•If recommended by the attending physician, CT or MR perfusion should be performed prior to NBHO
•NBHO can be initiated within 6 hours of symptom onset (witnessed) or symptom recognition (in case of wake\-up or unknown onset stroke), and within 30 minutes after last image of baseline brain Imaging
•Pre\-stroke mRS of 0 to 2
•Breastfeeding women must stop breastfeeding after randomization.
•Own written informed consent is not obtained prior to study inclusion but has to be gained as soon as possible. Patients who are able to give consent will be informed about trial participation orally and may consent to or decline participation. Patients unable to give consent will be enrolled through a deferred consent procedure (see Section 14\.5 Subject Information and Informed Consent).

•Neurological:
•TBY procedure initiated (groin puncture) prior to randomization.
•Rapid major improvement in neurological status prior to randomization.
•Any condition which precludes obtaining an accurate baseline NIHSS or outcome assessment (e.g. seizures, dementia, psychiatric or neuromuscular disease).
•Intracranial hemorrhage (except of cerebral microbleeds), intracranial tumor (except small meningioma), and/or intracranial arteriovenous malformation.
•Intracranial aneurysm or prior stent implantation in the vascular territory (upstream and downstream) affected by qualifying LVO.
•Suspected complete common carotid artery (CCA) occlusion, aortic dissection, cerebral vasculitis, septic embolism, or bacterial endocarditis.
•Acute bilateral stroke or stroke in multiple vascular territories (except of clinically silent micro\-lesions).
•Respiratory:
•Acute or chronic pulmonary disease or respiratory distress that may, in the clinical judgement of the investigator, interfere with the study intervention (e.g. acute pneumonia, COPD flare\-up etc.)