Quantifying Brain Oxygenation Index for Thrombectomy Outcome Assessment Study

Quantifying Brain Oxygenation Index for Thrombectomy Outcome Assessment Study - Q-BOT study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054214

Enrollment

100

Registered

2024-04-22

Start date

2023-08-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing endovascular reperfusion therapy for cerebral infarction due to acute occlusion of the main cerebral artery (internal carotid artery or middle cerebral artery)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who satisfy the following (1) to (6) (1) Patients who undergo endovascular reperfusion therapy within 24 hours of onset for cerebral infarction caused by occlusion of the main artery (internal carotid artery or middle cerebral artery M1, M2, or beyond) (2) TD-NIRS measurement is performed in the usual medical examination (3) 18 years of age or older (4) Independent in daily life before onset (mRS 2 or less) (5) Cerebral infarction severity at presentation with NIHSS > 4 (6) Patients who have obtained written consent from the patient or a surrogarate

Exclusion criteria

Exclusion criteria: Patients who satisfy the following (1) or (2) (1) Patients who are currently participating in another clinical trial (2) Patients who are judged by the physician to be unsuitable for the clinical trial (3) Pregnant patients

Design outcomes

Primary

Measure	Time frame
Relationship between TD-NIRS measurements and cases of functional independence (modified Rankin Scale 0-2) after 3 months in effective reperfusion cases	—

Secondary

Measure	Time frame
Relationship between TD-NIRS measurements and Preoperative ischemia severity (NIHSS) Ischemic core volume and penumbra volume and their ratio on preoperative CT perfusion imaging Percentage of good collateral perfusion on preoperative CT angiography and cerebral angiography Degree of reperfusion (expanded TICI grade) and presence of early venous drainage on cerebral angiography at the end of the procedure Number of procedures performed in patients with complete reperfusion on cerebral angiography Ischemic core volume and penumbra volume and their ratios in the immediate postoperative CT perfusion images Infarct expansion within 24 hours after surgery Symptomatic intracranial hemorrhage within 24 hours after surgery Early improvement of neurological symptoms within 24 hours after surgery	—

Measure

Time frame

Relationship between TD-NIRS measurements and Preoperative ischemia severity (NIHSS) Ischemic core volume and penumbra volume and their ratio on preoperative CT perfusion imaging Percentage of good collateral perfusion on preoperative CT angiography and cerebral angiography Degree of reperfusion (expanded TICI grade) and presence of early venous drainage on cerebral angiography at the end of the procedure Number of procedures performed in patients with complete reperfusion on cerebral angiography Ischemic core volume and penumbra volume and their ratios in the immediate postoperative CT perfusion images Infarct expansion within 24 hours after surgery Symptomatic intracranial hemorrhage within 24 hours after surgery Early improvement of neurological symptoms within 24 hours after surgery

—

Countries

Japan

Contacts

Public ContactDaisuke Maruyama

Kyoto Prefectural University of Medicine Neurosurgery

dmaruyam@koto.kpu-m.ac.jp075-251-5541

Outcome results