Health Condition 1: G46- Vascular syndromes of brain in cerebrovascular diseases
Conditions
Interventions
Intervention1: TENECTEPLASE INJECTION: Eligible patients shall be randomly assigned as per block randomization to intravenous thrombolytic agent. Eligible patients shall be given intravenous thrombol
Sponsors
AIIMS JODHPUR
Eligibility
Inclusion criteria
Inclusion criteria: age more than or equal to 18 years, patients with acute ischemic stroke, onset of symptoms less than 4.5 hours, if exact time of stroke is unknown,it is defined as the last time the patient was known to be normal or at neurologic baseline. Wake up stroke-patients with acute ischemic stroke who wake up with stroke symptoms or have unclear time of onset more than 4.5 hours from last known wellor at baseline state and who have a DW-MRI lesionsmaller than one third of the MCA territory and no visible signal change on FLAIR . Diffusion FLAIR mismatch. Informed and signed consent.
Exclusion criteria
Exclusion criteria: Ischemic stroke or severe head trauma in previous three months, previous intracranial haemorrhage, patient with intracerebral haemorrhage in NCCT head, persistent blood pressure elevation( SBP more than or equal to 185 mm hg or DBP more than or equal to 110 mm hg), intra-axial intracranial neoplasm, Gastrointestinal malignancy, Gastrointestinal haemorrhage in previous 21 days, Infective endocarditis, Aortic arch dissection, Acute head trauma, Subarachnoid haemorrhage, Minor non disabiling stroke, Intracranial or intraspinal surgery within prior 3 months, major surgery in preceeding 14 days, recent history of ICH, subarachnoid haemorrhage, AVM, aneurysm or cerebral neoplasm, Arterial puncture at non compressible site in previous 7 days, acute bleeding diasthesis, platelet count less than 1 lakh/mm3, pregnant female, non availability of inr if patient is on vka, current anticoagulant use with inr more than 1.7 or pt more than 15 seconds or aptt more than 40 seconds, therapeutic doses of low molecular heparin received within 24 hours example to treat vte and acs, this exclusion doesnot apply to prophylactic dose,example to prevent VTE, Use of glycoprotein IIbIIIa inhibitors within past 72 hours, patient of acute ischemic stroke who are thrombolysed outside the study centre, Current use (that is last dose within 48 hours in a patient with normal renal function) of a direct thrombin inhibitor or direct factor Xa inhibitor with evidence of anticoagulant effect by laboratory tests such as APTT,INR,ECT,TT or appropriate factor Xa activity assays, patient who gave negative consent for intravenous thrombolysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in NIHSS at 24 hours and at 72 hours post thrombolysisTimepoint: 24 hours and 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.mRS at 1 month and at 3 months 2.Radiological evolution on the basis of NCCT head and CTA 3.need for decompression surgeryTimepoint: mRS- 1 month and 3 months, radiological evolution- baseline and at 24 hours after thrombolysis | — |
Countries
India
Contacts
Public ContactDr Samhita Panda
AIIMS Jodhpur
Outcome results
None listed