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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
| Beijing Municipal Science & Technology Commission | OTHER |
| Beijing Municipal Administration of Hospitals | OTHER_GOV |
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The aim of the study was to establish tenecteplase thrombolysis database and to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients.
Tenecteplase (TNK), as a newer fibrinolytic agent, has practical delivery advantages over alteplase that would make it a potential alternative. Several randomized controlled clinical trials demonstrated the noninferiority of TNK but the evidence on the effectiveness and safety of TNK in the real-world is insufficient.
This is a multi-center, prospective, registry cohort study that enrolled acute ischemic stroke patients treated with TNK thrombolysis in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhTNK-tPA Thrombolysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhTNK-tPA Thrombolysis | Drug | rhTNK-tPA Thrombolysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Excellent functional outcome at 90 days | proportion of mRS score 0-1 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome | 3 months after thrombolysis |
| Measure | Description | Time Frame |
|---|---|---|
| Favorable functional outcome | proportion of mRS score 0-2 at 3 months | 3 months after thrombolysis |
| Walk independence | proportion of mRS score 0-3 at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic intracerebral hemorrhage at 36 hours | symptomatic intracerebral hemorrhage as defined by ECASSIII: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration, as defined by an increase of 4 points or more in the score on the NIHSS, or that led to death and that was identified as the predominant cause of the neurological deterioration. |
Inclusion Criteria:
Exclusion Criteria:
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acute ischemic stroke patients treated with rhTNK-tPA and derivatives in China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunyun Xiong, MD, PhD | Contact | 00861059975213 | xiongyunyun@bjtth.org |
| Name | Affiliation | Role |
|---|---|---|
| Yunyun Xiong, MD, PhD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yunyun Xiong | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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serum sample
| 3 months after thrombolysis |
| Ordinal distribution of mRS at 90 days | Number of participants with the ordinal distribution of mRS at 90 days | 3 months after thrombolysis |
| Neurological improvement at 24 hours | NIHSS score <=1 or improvement of NIHSS score>=4 compared with baseline NIHSS. National Institution Health Stroke Scale (NIHSS) has a minimum value of 0 and maximum value of 45. Higher value indicated worse severity of neurological impairment. | 24 hours after thrombolysis |
| NIHSS score at discharge | NIHSS score at 5-7 days or at discharge | 5-7days after thrombolysis or at discharge |
| EQ-5D score at 90 days | EQ-5D score at 3 months. EuroQol Five Dimensions Questionnaire scale (EQ-5D score) has a minimum value of 0 and maximum value of 100. Lower value indicated worse functional outcome | 3 months after thrombolysis |
| Barthel(BI) at 90 days | Global function of daily living defined as BI ≥ 95 at 90 days | 3 months after thrombolysis |
| 36 hours after thrombolysis |
| Hemorrhage in other parts | The proportion of patients with other bleeding events was defined by GUSTO bleeding at 90 days | 36 hours after thrombolysis |
| Mortality at 90 days | Mortality of all-cause | 90 days after thrombolysis |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |