Anaesthesiological Routine Care for Thrombectomy in Cerebral Ischaemia

NCT04522856 | Recruiting DMC

• 1 other identifier: ARCTIC-I
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

Endovascular thrombectomy is the standard of care for acute ischaemic stroke due to large-vessel occlusion. Current guidelines for periprocedural anaesthesiological care give gross recommendations on management of stroke patients during recanalization, but lack detailed information. To determine how anaesthesiologists support endovascular thrombectomy with regard to anaesthetic technique, choice of substances, haemodynamic management, and ventilation. With a multivariate analysis, the investigators will look for the factors of anesthetic management that are independently correlated with a good or bad outcome.

Conditions

Cerebral Ischemia

Keywords

Endovascular thrombectomy; acute ischaemic stroke; large-vessel occlusion

Outcome Measures

Primary Outcomes (1)

• Neurological outcome 90 days after the stroke

  Neurological outcome is measured using the modified Rankin Scale \[0-6\], with higher values indicating worse outcome. As a Primary Outcome Measure, the scale will be dichotomized into good (modified Rankin Scale ≤ 2) versus poor (modified Rankin Scale \> 2) outcome.

  90 days

Secondary Outcomes (4)

• Mortality

  90 days

• Grade of recanalization

  sixty minutes

• Duration

  30 Minutes

• Proportion of patients breathing spontaneously

  sixty minutes

Study Arms (1)

Endovascular thrombectomy

there is only one group of the subjects that had stroke and went under thrombectomy procedure and to see how anaesthesiologists support endovascular thrombectomy with regard to anaesthetic technique,choice of substances, haemodynamic management, and ventilation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population consists of patients undergoing emergency endovascular thrombectomy for treatment of AIS-LVO. The planned minimum sample size is 5,000 patients.

You may qualify if:

• Endovascular stroke treatment involving anaesthesia care

You may not qualify if:

• In-hospital onset of stroke
• Age under 18 years

Sponsors & Collaborators

• European Society of Anaesthesiology: lead

Study Sites (1)

TU München

München, Germany

RECRUITING

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andreas Ranft, Dr.

  Senior Physician-München, Germany

  STUDY CHAIR

Central Study Contacts

Andreas Ranft, Dr.

CONTACT

004989 4140 9632; andreas.ranft@tum.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: August 21, 2020
• Study Start: August 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: August 30, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)