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| Name | Class |
|---|---|
| Lumpang Hospital | UNKNOWN |
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Cohort A Randomized Control trial of Ateplase 0.6, 0.75 and 0.9 mg/kg in 78 patients Cohort B single arm 0.9 mg/kg Ateplase in 330 patients Combined Cohort A and B evaluate different of death, intra-cerebral hemorrhage, numberof patient with mRS 0-1 at discharge and 3 months follow up, and other important stroke outcomes
We conducted the prospective study to compare the low-dose and standard-dose rtPa and identify the important factors predicted stroke outcomes in acute stroke patient received intravenous rtPa. In Cohort A, During 2011-2012, 78 patients were randomly assigned to received intravenous rtPa 0.6 mg/kg , 0.75 mg/Kg, or 0.9 mg/Kg (1:1:1). After interim analysis during 2012-2017, in Cohort B, 330 patients were assigned to receive standard-dose rtPa 0.9 mg/kg. The good outcomes were defined as improvement of modified Rankin scale (mRS) by final score 0-1 or improvement > 4 points at discharge or 3 months follow up, absent of intracranial hemorrhage within 36 hours treatment, 90-day post-stroke survival , and short hospital length of stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.6 mg/kg Ateplase | Active Comparator | Low dose 0.6 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke (n = 26 in cohort A) |
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| 0.75 mg/kg Ateplase | Active Comparator | Low dose 0.75 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke(n = 26 in cohort A) |
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| 0.9 mg/kg Ateplase | Active Comparator | Low dose 0.9 mg/kg Ateplase injection with in 4.5 Hr after onset of stroke(n = 26 in cohort A and n= 330 in Cohort B) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Solution Ateplase | Drug | Infusion Low dose 0.6 or 0.75 or 0.9 mg/kg Ateplase injection iv bolus 10% of total dose and infusion 90% of total dose in1 hour , with in 4.5Hr after onset of stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Death in 36 hours | Number of patient die in 36 hours | 0-36 hours |
| Death in 3 months | Number of patient die in 3 months | 0-3 months |
| Death in 4 months | Number of patient die in 4 months | 0-4 months |
| Total number of patients with mRS 0-1 at discharged | Number of patients with mRS 0-1 at discharge 1day to 3 months interval | 1day to <3 months |
| Total number of patients with mRS 0-1 at 3 months | Number of patients with mRS 0-1 at 3 months | At 3 months |
| Number of patients with All intra-cerebral hemorrhage (ICH) at 36 hours | Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH | 0- 36 hours |
| Number of patients with All intra-cerebral hemorrhage (ICH) at 3 months | Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH | 0-3 months |
| Number of patients with All Intra-cerebral hemorrhage (ICH) at 4months | Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH |
| Measure | Description | Time Frame |
|---|---|---|
| Good stroke outcomes | Total number of patients with "good outcomes" were defined as number of patients with this any one item criteria
1) absent of intracranial hemorrhage within 36 hours treatment and 2) survive at 90-day post-stroke ,and 3) short hospital length of stay less than 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistant Professor Subsai Kongsaengdao | Bangkok | 10400 | Thailand |
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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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Cohort A double blind Randomized controlled trial 0.6 or 0.7 or 0.9 mg/Kg Ateplase in78 patients (preliminary) Cohort B single arm standard dose 0.9 mg/kg Ateplase in 330 patients
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| 0-4 months |
| Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 36 hours | Total Number of patients with Symptomatic ICH need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration | 0-36 hours |
| Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 4 months | Total Number of patients with Symptomatic ICH need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration | 0-4 months |
| Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 36 hours | Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration | 0-36 hours |
| Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 3 months | Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration | 0-3 months |
| Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 4 months | Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration | 0-4 months |
| 0-4 months |
| Improved mRS at discharge | Number of patients with improve mRS after treatment at least 1 Score | (At discharge) 1 day to 3 months |
| Improved mRS 3 months | Number of patients with improve mRS after treatment at least 1 Score | At 3 months |
| Number of patienta with Length of hospital stay (LOS) less than 7 days Days | Number of patients with LOS < 7 days ( patients must survive ) | 1- 7 days |
| All complications | Number of patients with stroke complications after treatment | 0-4 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |