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Penumbral Rescue by Normobaric O2 Administration in Patients With Ischemic Stroke and Target Mismatch ProFile

NCT03500939 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2022-09-23

No results posted yet for this study

Summary

The main objective of the PROOF trial is to investigate efficacy and safety of normobaric hyperoxygenation (NBHO) as a neuroprotective treatment in patients with acute ischemic stroke due to large vessel occlusion likely to receive endovascular mechanical thrombectomy (TBY) in a randomized controlled clinical phase IIb trial.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

Medical oxygen

inhalation of 100% oxygen at high flow via a sealed non-rebreather face-mask with reservoir

OTHER

Standard of care

e.g. thrombectomy, thrombolysis

Sponsors & Collaborators

  • Coordination Centre for Clinical trials (KKS), 69120 Heidelberg, Germany

    collaborator UNKNOWN

  • European Clinical Research Infrastructure Network (ECRIN), 10559 Berlin, Germany

    collaborator UNKNOWN

  • CORE IMAGING LABORATORY: Eppdata GmbH, 22529 Hamburg, Germany

    collaborator UNKNOWN

  • CORE BIOMARKER LABORATORY: Fundatio Hospital Universitari Vall d'Hebron, 08035 Barcelona, Spain

    collaborator UNKNOWN

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Sven Poli, MD · University Hospital Tübingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-05-16
Completion
2022-08-22

Countries

  • Belgium
  • Finland
  • France
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03500939 on ClinicalTrials.gov