Time Is Brain, One Bolus at a Time: A Retrospective Evaluation of Weight-Based Tenecteplase Vs Alteplase Dosing and Clinical Outcomes for Acute Ischemic Stroke

Document Type

Conference Proceeding

Publication Date

3-6-2026

Publication Title

Am J Health Syst Pharm

Keywords

alteplase, fibrinolytic agent, tenecteplase, adult, bleeding, brain hemorrhage, cerebrovascular accident, clinical outcome, cohort analysis, conference abstract, contraindication, electronic health record, female, Food and Drug Administration, Glasgow coma scale, human, length of stay, major clinical study, male, medical record review, National Institutes of Health Stroke Scale, prisoner, Rankin scale, retrospective study, side effect

Abstract

Purpose: Alteplase (tPA) was the only FDA-approved fibrinolytic for acute ischemic stroke (AIS) until Tenecteplase (TNK) received approval in March 2025. TNK’s simplified single-bolus administration has led to widespread use, but new FDA tiered dosing recommendations have raised concerns regarding bleeding risk compared to the traditional 0.25 mg/kg (maximum 25 mg) regimen. Historically, Henry Ford Jackson Hospital used tPA but later transitioned to TNK under a weight-based protocol prior to FDA recommendations. This study aims to evaluate the safety and efficacy of TNK compared to historical tPA controls, assess adherence to institutional dosing, and inform adoption of updated FDA-approved dosing practices. Methods: This study is approved by the Henry Ford Institutional Review Board as a retrospective chart review. The primary endpoint is to compare adverse events between patients who received TNK to historical controls who received tPA, including intracranial hemorrhage, other bleeding events, and mortality at 30 and 90 days. Secondary endpoints will assess efficacy outcomes such as NIHSS, Glasgow Coma Scale, modified Rankin score (mRS), hospital length of stay, discharge disposition and adherence to institutional TNK dosing protocol. Subgroups analysis will evaluate outcomes in low and high weight patients to explore whether FDA-approved tiered TNK dosing may increase adverse events. Eligible patients are adults (≥ 18 years) with confirmed AIS at Henry Ford Jackson Hospital. Patients treated between May 1st, 2021 to April 30st, 2023 will comprise the tPA group, while those treated between August 1st, 2023 to July 31st, 2025 will comprise the TNK group. A three-month period from May to July 2023 will account for the transition to TNK. Exclusion criteria include transfer from outside hospital, contraindications to fibrinolytics, incomplete or missing data, misdiagnosed stroke, and prisoner status. Data will be extracted from electronic health records, de-identified, and stored securely. Statistical analyses will include independent samples t-test, Wilcoxon Rank Sum test, Chi-squared test, or Fisher’s Exact test as appropriate. A 2-tailed p-value < 0.05 will define significance.

Volume

83

Issue

Supplement_2

First Page

S808

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