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The interim analysis showed the potential harm of intra-arterial TNK.
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| Name | Class |
|---|---|
| Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning | UNKNOWN |
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The potential benefit of intraarterial tenecteplase in acute basilar artery occlusion (BAO) patients with successful reperfusion following endovascular treatment (EVT) has not been studied. The current study aimed to explore the efficacy and safety of intraarterial tenecteplase in acute BAO patients with successful reperfusion after EVT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNK group | Experimental |
| |
| control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase | Drug | intra-arterial tenecteplase |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of favorable functional outcome | favorable functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 3 | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with an improved modified thrombolysis in cerebral infarction score | immediately after intraarterial TNK administration or at the end of endovascular treatment | |
| the proportion of patients with modified Rankin Score (mRS) 0 to 1 | mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Northern Theater Command | Shenyang | 110840 | China |
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| Day 90 |
| the proportion of patients with modified Rankin Score (mRS) 0 to 2 | mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death. | Day 90 |
| ordinal distribution of modified Rankin Score (mRS) | mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death. | Day 90 |
| change in modified Rankin Score (mRS) compared with premorbid mRS | mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death. | Day 90 |
| change in National Institute of Health stroke scale (NIHSS) | NIHSS scores range from 0 to 42, with higher scores indicating more severe neurological deficit | 24 (-6/+24) hours |
| proportion of early neurological improvement | early neurological improvement is defined as a NIHSS decrease ≥4 | 24 (-6/+24) hours |
| change in the cerebral circulation time | immediately after tenecteplase |
| the occurrence rate of composite events of recurrent stroke, cardiovascular or cerebrovascular events | Day 90 |
| proportion of sympomatic intracranial hemorrhage | sympomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage | 24 (-6/+24) hours |
| proportion of intraparenchymal hemorrhage | intraparenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect | 24 (-6/+24) hours |
| the percentage of severe adverse events | 24 (-6/+24) hours |
| cerebral edema | cerebral edema was measure by the mount of midline shift of the brain on neuroimaging | 24 (-6/+24) hours |
| all-cause mortality | 10 days |
| the number of tenecteplase infusions interrupted due to suspected active bleeding | during endovascular treatment (up to 2 hours) |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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