EUCTR2017-001355-31-FI
Active, not recruiting
Phase 1
Penumbral Rescue by Normobaric O=O Administration in Patients with Ischemic Stroke and Target Mismatch ProFile:A Phase II Proof-of-Concept Trial - PROOF
Eberhard-Karls University Tübingen represented by University Hospital Tübingen and its Commercial Director0 sites223 target enrollmentSeptember 28, 2018
ConditionsAcute ischemic strokeMedDRA version: 20.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsMedical oxygen
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute ischemic stroke
- Sponsor
- Eberhard-Karls University Tübingen represented by University Hospital Tübingen and its Commercial Director
- Enrollment
- 223
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 18 to 80 years
- •Clinical signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke
- •LVO on CT angiography or MR angiography consistent with clinical signs and symptoms, i.e. either the terminal ICA with involvement of the M1\-segment of the MCA/carotid\-T, the proximal M1\-segment, or the distal M1\-segments (distal to perforating branches)
- •NIHSS score of \= 6 at screening
- •NIHSS item 1a (level of consciousness) of 0 or 1
- •Alberta Stroke Program Early CT score (ASPECTS) of 7\-10 on non\-contrast CT or 6\-10 on diffusion\-weighted MRI (DWI\-MRI)
- •CT perfusion (preferably whole\-brain, minimal coverage \= 75 mm) or MR perfusion imaging performed prior to NBHO
- •NBHO can be initiated within 3 hours of certain stroke symptom onset (witnessed or last seen well) and within 20 minutes after end of baseline brain imaging (i.e. within 20 minutes after last image)
- •Pre\-stroke mRS of 0 or 1
- •Due to the emergency situation in which patients are enrolled and the presumed safety of the IMP as applied in the PROOF trial, their 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
Exclusion Criteria
- •Neurological:
- •Rapid improvement in neurological status to an NIHSS \< 6 or evidence of vessel recanalization prior to randomization
- •Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment
- •Acute neurological symptoms related to other pathology than ischemic stroke
- •Evidence of intracranial hemorrhage (except of cerebral microbleeds), intracranial tumor (except small meningioma), and/or intracranial arteriovenous malformation as confirmed by baseline brain imaging
- •Intracranial aneurysm or prior stent implantation in the vascular territory (upstream and downstream) affected by qualifying LVO
- •TBY procedure initiated (groin puncture) prior to randomization
- •Previously known or CT angiographic / MR angiographic visualization of ipsilateral high\-grade stenosis, complete cervical carotid occlusion, or flow\-limiting carotid dissection
- •Suspected aortic dissection or cerebral vasculitis based on medical history or CT angiography / MR angiography
- •Clinical or imaging evidence of acute bilateral stroke or stroke in other vascular territories than qualifying LVO (except of clinically silent micro\-lesions on DWI\-MRI in patients who received MR\-based acute brain imaging)
Outcomes
Primary Outcomes
Not specified
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