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| Name | Class |
|---|---|
| Department of Science and Technology of Shanxi Province | UNKNOWN |
| Air Force Military Medical University, China | OTHER |
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The purpose is to evaluate the effectiveness and safety profile of telemedicine consultation system in making decision on IV thrombolysis.
The rate of intravenous thrombolysis with tissue-type plasminogen activator or urokinase for stroke patients was extremely low in China. It has been demonstrated that telestroke may help to increase the rate of intravenous thrombolysis and improve the stroke care quality in the local hospitals. The aim of this study is to evaluate the effectiveness and safety of decision making of intravenous thrombolysis via telemedicine consultation system for acute ischemic stroke patients in China This trial network consists of one hub hospital (Xijing Hospital) and 14 spoke hospitals in the remote area of Shanxi Province. The telemedicine consultation system is an interactive, 2-way, wireless, audiovisual system based on portable hardwares--tablet computer or smartphone. Before this study, we have been investigating the usual stroke care quality in the spoke hospitals without the guidance from the hub hospital, which will be used as the historical control of this study. After that, the teleconsultation system will be introduced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teleconsultation | Intravenous thrombolysis guided by telemedicine consultation system based on portable hardwares |
| |
| Historical control | Usual stroke care without the guidance from hub hospital |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine consultation system | Other | Telemedicine consultation system based on portable hardwares |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients treated with intravenous thrombolysis | at 4.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Favorite outcome at 3 months (modified Rankin score ≤2) | at 1 month/3 months | |
| Stroke complications | They include symptomatic intracranial hemorrhage (sICH), symptomatic cerebral edema from an original brain infarction, cerebral hernia, seizure, severe extracranial bleeding, pulmonary embolism, pulmonary edema, deep venous thrombosis, and sepsis. |
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Inclusion Criteria:
Exclusion Criteria:
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Ischemic stroke patients arriving in the local hospitals within 4.5 hours of symptom onset
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziwen Yuan, MD | Contact | yuan0929rong@hotmail.com | ||
| Zhirong Liu, MD | Contact | liuzhir@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhirong Liu, MD | Xijing Hospital | Principal Investigator |
| Gang Zhao, MD | Xijing Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xingyuan Hospital | Recruiting | Yulin | Shanxi | 719000 | China | |
| Yulin First People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25979867 | Derived | Yuan Z, Wang B, Li F, Wang J, Zhi J, Luo E, Liu Z, Zhao G. Intravenous thrombolysis guided by a telemedicine consultation system for acute ischaemic stroke patients in China: the protocol of a multicentre historically controlled study. BMJ Open. 2015 May 15;5(5):e006704. doi: 10.1136/bmjopen-2014-006704. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| at 24 hours/7days |
| Fatal and nonfatal cardiovascular events | They include recurrent ischemic stroke, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attack, myocardial infarction, angina and heart failure | at 7 days |
| All cause mortality | at 3 months |
| Time intervals | Those from stroke onset to arriving in emergency department(ED), and from arriving in ED to physician/CT initiation/CT interpretation/specific treatment. | at 24 hours |
| Length of hospitalization | at 3 months |
| Not yet recruiting |
| Yulin |
| Shanxi |
| 719000 |
| China |
| Yulin Second People's Hospital | Recruiting | Yulin | Shanxi | 719000 | China |
| Yuyang District People's Hospital | Not yet recruiting | Yulin | Shanxi | 719000 | China |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |