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an exploratory study of the brief local brain hypothermia in combination with endovascular thrombectomy for patients with t-PA refractory cerebral ischemia in internal carotid artery territory

an exploratory study of the brief local brain hypothermia in combination with endovascular thrombectomy for patients with t-PA refractory cerebral ischemia in internal carotid artery territory - tPA COOL IVR study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018255
Enrollment
7
Registered
2015-07-10
Start date
2015-07-10
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

Cerebral infarction

Interventions

Brief Local Brain hyporhermia

Sponsors

Hokkaido University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who are able to be treated with endovascular embolectomy after intravenous tPA in 8 hours from the onset. 2) Patients who needs endovascular thrombetomy because of severe cerebral ischemia by occlusion of the main trunk in internal carotid artery system. 3) Patients with symptom (NIHSS>=5)after recanalization. 4)Written informed consent provided by the patient or his/her family member.

Exclusion criteria

Exclusion criteria: 1) Patients who cannot be submitted to angiography due to severe iodine allergy. 2) Patients with very light symptoms or quick improvement. 3) Patients with hemorrhagic lesions. 4) Patients with severe hepatic or renal disorder. 5) Patients with multiorgan failure or DIC due to cancer. 6) Patients with uncotrolled hypertention (systolic>185mmHg, diastoric >110mmHg). 7) Patients with uncotrolled glucose levels (<50 mg/dl, >400 mg/dl). 8) Patients with platelet count <100,000 /mm3. 9) Patients who are not suitable for the study in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
The safety

Secondary

MeasureTime frame
1.The assessment of controlling the symptom after re-perfusion injury. 2.The assessment of infarction and cerebral edema due to images 3.the assessment of physical findings and clinical examination

Countries

Japan

Contacts

Public ContactToshiya Osanai

Hokkaido University Hospital Department of Neurosurgery

osanait@med.hokudai.ac.jp011-706-5987

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026