Health Condition 1: G811- Spastic hemiplegia
Conditions
Interventions
Intervention1: Tenecteplase: Intravenous Tenecteplase will be used at a dose of 0.25mg/kg at a maximum dose of 20mg.
Control Intervention1: Intravenous recombinant Tissue Plasminogen Actoivator (rTPA)
Sponsors
Dr Rohit Bhatia
INSTRUCT Network
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age 18 years and above. 2) Patients with Acute ischemic stroke 3) Within 4.5 hours of onset 4) NIHSS greater than or equal to 5 5) Presence of a proximal large vessel occlusion. ( M1 MCA, proximal M2 MCA, distal ICA, Basilar artery) on CTA/MRA. 6) Eligible for thrombolysis as per current inclusion and exclusion criteria. 7) Eligible for endovascular treatment as per the current protocol. 8 ) Agree for endovascular therapy as a part of standard treatment for LVO. 9 ) ASPECTS score (Alberta Stroke Program Early CT score) greater than or equal to 6 10) Informed and signed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with intracerebral hemorrhage. 2. Hypodensity in greater than one third of MCA territory 3. Recent ischemic stroke within three months 4. ASPECTS less than 6. 5. Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. 6. Current use of oral anticoagulation with Vitamin K antagonist with INR greater than or equal to 1.7 as per current guidelines. 7. Non-Availability of INR if patient is on Vitamin K antagonist. 8. Current use of novel oral anticoagulants (NOAC’s). 9. Active use of heparin in therapeutic doses. 10. Use of glycoprotein IIb-IIIa inhibitors within the past 72 hours. 11. Clinically significant hypoglycemia. 12. Persistently elevated blood pressure greater than 185 mmHg systolic or 110 mmHg diastolic (as per standard thrombolysis guidelines). 13. Hereditary or acquired hemorrhagic diathesis 14. Gastrointestinal or urinary bleeding within the preceding 21 days 15. Major surgery within the preceding 14 days which poses risk 16. Any recent cranial, spinal surgery within 3 months. 17. Baseline mRS greater than or equal to 2 18. Active Pregnancy 19. Contraindication to contrast agents 20. Intra-cardiac tumor. 21. Active Subacute bacterial endocarditis. 22. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Proportion of patients who will be independent at 3 months ( using modified Rankin score; mRS less than or equal to 2 taken as a good outcome) 2) Proportion of patients who achieve recanalization mTICI grade 2b or 3 at first angiography run.Timepoint: At the end of procedure 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients who achieve mTICI grade 2b/3 (appendix 5) at the end of the EVT procedure. 2. Proportion of patients with early Neurological improvement (ENI) defined as improvement of NIHSS by 4 points at 24 hours. 3. Rate of symptomatic ICH as defined using SITS MOST criteria 4. Rate of any ICH 5. Rate of any systemic major or minor bleeding using GUSTO classification. 6. Rate of mortality at 3 months. 7. Duration of hospital stay.Timepoint: 24 hours to 72 hours after intervention 3 months | — |
Countries
India
Contacts
Public ContactRohit Bhatia
All India Institute of Medical Sciences. New Delhi.
Outcome results
None listed