Effect of xenon on brain injury, neurological outcome and survival in patients after aneurysmal subarachnoid hemorrhage

Phase 1

• Conditions: MedDRA version: 20.0Level: HLTClassification code: 10007962Term: Central nervous system vascular disorders NEC Class: 10029205; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; Aneyrysmal subarachnoid hemorrhage needing ventilatory care in intensive care unit

• Registration Number: CTIS2022-500596-32-00
• Lead Sponsor: Turku University Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

To be considered eligible to participate in this study, a SAH subject must meet the inclusion criteria listed below: 1.Informed consent obtained from the next of kin or legal representative 2.Aneurysmal subarachnoid hemorrhage visible on CTA or DSA. 3.Deterioration of consciousness to Hunt-Hess 3-5 4.Age of = 18 years 5.Intubated. 6.GCS 3–12 obtained off neuromuscular blocking agents 7.Xenon treatment can be started within 6 hours after onset of SAH symptoms

Exclusion Criteria

Acute or chronic traumatic brain injury, Current enrollment in another interventional study, The subject is known to have clinically significant laboratory abnormality, medical condition (such as decompensated liver disease or severe chronic obstructive pulmonary disease), or social circumstance that, in the investigator’s opinion, makes it inappropriate for the subject to participate in this clinical trial, Presence of implants or foreign bodies which are not known to be MRI safe, Maximum diameter of intracerebral hemorrhage > 2.5 cm, Pneumothorax or pneumomediastinum, Acute lung injury requiring = 60% FIO2 (fraction of inspired oxygen), Systolic arterial pressure < 80 mmHg or mean arterial pressure < 60 mmHg for over 30 min period, Bilaterally fixed and dilated pupils, Positive pregnancy test, known pregnancy, or current breast-feeding, Neurological deficiency due to traumatic brain injury or other neurological illness, Imminent death or current life-threatening disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified