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

Phase 1

• Conditions: Acute rupture of cerebral aneurysm, subarachnoid hemorrhage (SAH), unconsciousness, brain injury.; MedDRA version: 20.1Level: LLTClassification code 10008078Term: Cerebral arterial aneurysmSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-001542-17-FI
• Lead Sponsor: Timo Laitio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-08
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Aneurysmal subarachnoid hemorrhage visible on CTA or DSA.
2. Hunt-Hess 3-5
3. Age of = 18 years
4. Intubated.
5. GCS 3–12 obtained off neuromuscular blocking agents
6. Xenon treatment started within 6 hours after onset of SAH symptoms

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Acute traumatic brain injury
2.Maximum diameter of intracerebral hemorrhage > 2.5 cm
3.Pneumothorax or pneumomediastinum,
4.Acute lung injury requiring = 60% FIO2 (fraction of inspired oxygen).
5.Systolic arterial pressure < 80 mmHg or mean arterial pressure < 60 mmHg for over 30 min period
6.Bilaterally fixed and dilated pupils
7.Positive pregnancy test, known pregnancy, or current breast-feeding
8.Chronic neurological deficiency due to chronic traumatic brain injury or other neurological illness
9.Imminent death or current life-threatening disease
10.Current enrollment in another interventional study
11.The subject is known to have a 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.
12.Presence of implants or foreign bodies which are not known to be MRI safe

Study & Design

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