Tenecteplase for the Treatment of Pediatric Arterial Ischemic Stroke: A Safety Surveillance Report

Neurology. 2025 Feb 11;104(3):e210310. doi: 10.1212/WNL.0000000000210310. Epub 2025 Jan 13.

Abstract

Objectives: Intravenous tenecteplase (TNK) is increasingly used to treat adult patients with acute arterial ischemic stroke, but the risk profile of TNK in childhood stroke is unknown. This study aims to prospectively gather safety data regarding TNK administration in children.

Methods: Since December 2023, a monthly email survey was sent to participants recruited from the International Pediatric Stroke Study and Pediatric Neurocritical Care Research Group querying recent experience with TNK in childhood stroke. Limited demographic, safety, and outcome data were collected in a secure REDCap database. Detailed clinical data were not collected.

Results: Eleven children were reported to have received TNK between February 2023 and January 2024. Ten were adolescents (13-17 years old), and 1 was between 5 and 12 years old. TNK was given at an outside facility before transfer to the reporting facility in 7 cases. Final diagnosis was stroke in 8 cases and stroke mimic in 3 cases. No major safety concerns or TNK-related intracranial hemorrhages on follow-up imaging were reported.

Discussion: Our initial data suggest that TNK may be safe in childhood arterial ischemic stroke. Strategically designed prospective studies are needed to further define safety, optimal dosage, and efficacy of TNK in acute pediatric stroke.

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Female
  • Fibrinolytic Agents* / adverse effects
  • Fibrinolytic Agents* / therapeutic use
  • Humans
  • Ischemic Stroke* / drug therapy
  • Male
  • Prospective Studies
  • Tenecteplase* / adverse effects
  • Tenecteplase* / therapeutic use
  • Tissue Plasminogen Activator / administration & dosage
  • Tissue Plasminogen Activator / adverse effects
  • Tissue Plasminogen Activator / therapeutic use
  • Treatment Outcome

Substances

  • Fibrinolytic Agents
  • Tenecteplase
  • Tissue Plasminogen Activator