Abstract 160: Final Results of the Thrombolysis for Minor Ischemic Stroke With Proven Acute Symptomatic Occlusion Using TNK-tPA (TEMPO-1) Trial
Bibliographic record
Abstract
Background: Minor stroke and TIA with an intracranial occlusion are associated with a 20-30% risk of neurological deterioration and subsequent disability. TNK-tPA compared to alteplase is easier to administer, has a longer half-life, higher fibrin specificity and possibly a lower rate of intracranial hemorrhage. Therefore, it may be an ideal thrombolytic agent for recanalization in this population. Methods: TEMPO-1 was a multi-centre, prospective cohort, TNK-tPA dose-escalation, safety and feasibility trial. Patients with an NIHSS < 6, intracranial arterial occlusion on CTA, with no sign of well-evolved infarction who were treated within a 12h treatment window were enrolled. 50 patients were enrolled. The first 25 patients were treated at a dose of 0.1 mg/kg, and a second cohort of 25 patients treated at a dose of 0.25 mg/kg. Primary outcome was the rate of symptomatic intracranial (SICH) and extracranial hemorrhage. SICH was defined as a new ICH with ≥ 2 points worsening on the NIHSS. SITS-MOST definition of SICH was also assessed. Secondary outcomes include complete neurological (NIHSS 0-1) and functional (mRS 0-1) recovery at 90 days, recanalization at 4-8 h on CTA and minor bleeding. Results: Median baseline NIHSS was 2 (SD 1.24) and median age was 71 years (SD 18). Site of intracranial occlusions were: MCA-M1 (13), MCA-M2 (21), MCA-M3 (8), PCA-P1 (1), PCA-P2 (1) branches, vertebral artery/PICA (3) and undetermined (3). There was one SICH seen [2% (1/50), CI95 0.5%-10.6%], which was in the 0.25mg/Kg dose tier. There were no SICH by the SITS-MOST definition. For the 0.1mg/Kg dose tier recanalization between 4-8 hours post drug was complete in 21.7%, partial in 26.1% and no recanalization was seen in 52.2%. For the 0.25mg/Kg dose tier recanalization between 4-8 hours post drug was complete in 56.6%, partial in 13% and no recanalization was seen in 30.4%. 90-day disability and neurological outcome assessment will be available at the time of the International Stroke Conference. Conclusion: We have shown the safety and feasibility of thrombolysis with TNK-tPA in a minor stroke with intracranial occlusion population. Rates of recanalization are high in the 0.25mg/Kg tier and we have chosen this dose to proceed with a randomized controlled trial in this population.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".