Unique ID issued by UMIN | UMIN000018255 |
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Receipt number | R000021101 |
Scientific Title | 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 |
Date of disclosure of the study information | 2015/07/10 |
Last modified on | 2024/01/16 08:53:09 |
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
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
Japan |
Cerebral infarction
Neurosurgery |
Others
NO
the aim of this study is to estimate the safety of the brief local brain hypothermia for the patients with t-PA refractory cerebral ishcemia in internal carotid artery territory.
Safety
Exploratory
Explanatory
Phase I
The safety
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Brief Local Brain hyporhermia
20 | years-old | <= |
85 | years-old | >= |
Male and Female
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.
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.
7
1st name | |
Middle name | |
Last name | Kiyohiro Houkin |
Hokkaido University Graduate School of Medicine
Department of Neurosurgery
North 15 West 7, Kita, Sapporo 060-8638, Japan
011-706-5987
houkin@med.hokudai.ac.jp
1st name | |
Middle name | |
Last name | Toshiya Osanai |
Hokkaido University Hospital
Department of Neurosurgery
North 14 West 5, Kita, Sapporo 060-8648, Japan
011-706-5987
osanait@med.hokudai.ac.jp
Hokkaido University Hospital
Hokkaido University Department of Neurosurgery
Self funding
Japan
NO
北海道大学病院(北海道)
小樽市立病院(北海道)
北海道脳神経外科記念病院(北海道)
柏葉脳神経外科病院(北海道)
千歳市民病院(北海道)
2015 | Year | 07 | Month | 10 | Day |
None
Unpublished
none
2
The trial was terminated after only two recruits were received.
2024 | Year | 01 | Month | 16 | Day |
Acute ischemic stroke patients
Nothing of note.
None
There was no adversed events.
Terminated
2015 | Year | 07 | Month | 01 | Day |
2015 | Year | 07 | Month | 01 | Day |
2015 | Year | 07 | Month | 10 | Day |
2017 | Year | 07 | Month | 10 | Day |
2017 | Year | 07 | Month | 10 | Day |
2018 | Year | 01 | Month | 01 | Day |
2018 | Year | 04 | Month | 01 | Day |
2015 | Year | 07 | Month | 09 | Day |
2024 | Year | 01 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021101
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