Background: The TNKCAT trial represents an innovative approach to optimize timely reperfusion in the Mothership and Drip-and-Ship scenarios. The logistic advantage of a single bolus infusion of TNK (compared to 1-h infusion of tPA) would markedly reduce the needle-to-groin and Door-in- door-out time. The implementation of a quality improvement package (QIP) in the TNKCAT trial would directly improve the quality and efficiency of the Health Care System. In addition, an improvement of transfer models would reduce the cost of unnecessary transfers, together with the fact that TNK is up to 50% less expensive than tPA, makes the TNKCAT in firm line with the sustainability strategy of the National Health Care system. Outcomes: The aim of the present study is to determine the safety and efficacy of TNK (0.25mh/kg) compared to tPA (0.9 mg/kg) in patients with Large Vessel Occlusion (LVO) suspicion, candidates for thrombectomy, in both Mothership and Drip-and-Ship scenarios. Study Duration: 2 years. Patients will participate in the trial for 3 months. Study design: Multicentre, prospective, randomized open-label blinded endpoint (PROBE) phase III study in acute stroke patients with LVO suspicion within 4.5 hours of stroke onset, candidates for EVT. Patients will be randomized 1:1 to standard dose tPA (0.9 mg/kg) or TNK (0.25mg/kg) before EVT. Clinical, imaging and outcome data will be collected at baseline, 24-36 hours, day 3, day 5 and day 90. Estimated enrollment: 500 patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
Patients will be randomized 1:1 to standard dose tPA (0.9 mg/kg) or TNK (0.25mg/kg) before endovascular therapy (EVT)
Hospital Universitari Vall d'Hebron
Barcelona, Spain
RECRUITINGModified Rankin scale score at 3 months
Shift analysis of the modified Rankin scale score at 3 months
Time frame: 3 months
Mortality rate
Mortality at 3 months
Time frame: 3 months
Symptomatic intracerebral haemorrhage (ICH) and neurological deterioration
Symptomatic ICH defined as intracerebral haemorrhage (PH2) within 36 hours of treatment, combined with neurological deterioration leading to an increase of ≥ 4 points on the National institute of Health Stroke Scale (NIHSS) from baseline, or the lowest NIHSS value between baseline and 24 hours.
Time frame: 24 -36hours
Rates of mRS 0-1 at 3 months
Modified Rankin scale score (0-1) rates
Time frame: 3 months
Rates of mRS 0-2 at 3 months
Modified Rankin scale score (0-2) rates
Time frame: 3 months
Rates of pre-interventional recanalization
Recanalization rate
Time frame: during the procedure
Dramatic clinical recovery before endovascular treatment (EVT)
Dramatic clinical recovery before EVT (Improvement in \> 8 points in the NIHSS score or NIHSS score \< 2 before groin puncture)
Time frame: before the procedure
First pass TICI 3, final TICI 2b-3
Rates of first pass TICI 3, final TICI 2b-3
Time frame: immediately after the procedure
Distal embolization during EVT
Rates of distal embolization during EVT
Time frame: during the procedure
Needle-to-groin times and DIDO times
Differences in needle-to-groin times in Mothership patients and in DIDO times in Drip-and-Ship patients.
Time frame: immediately after the procedure
Time metrics between TNKCAT and non-TNKCAT centers
Differences in time metrics between TNKCAT and non-TNKCAT centers
Time frame: at the end of the study
Final infarct volume on follow up CT
Differences in final infarct volume on follow up CT
Time frame: 24-36 hours follow up
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