OUTSET Trial: Phase I Dose-Escalation Data for Urokinase in Acute Ischemic Stroke

A 15.3 KB document describes the OUTSET clinical trial, a prospective, single-center, phase I dose-escalation study investigating urokinase for acute ischemic stroke. The study, registered as NCT07047326, aims to determine the maximum tolerated dose across four weight-based levels (15,000, 20,000, 25,000, and 30,000 IU/kg). It was authored by Shengjun Wang and last updated on 2026-04 15.

Use Cases

• Model dose-limiting toxicity events based on the described primary endpoint of symptomatic intracranial hemorrhage and major bleeding.
• Analyze the relationship between weight-adjusted dosing and adverse events using the described four dose groups.
• Inform the design of future thrombolytic trials based on the maximum tolerated dose finding from the rolling-six study design.

Strengths

• The study protocol is clearly defined with four specific dose levels (15,000, 20,000, 25,000, and 30,000 IU/kg).
• Includes a clinical trial registration identifier (NCT07047326) for verification.
• Released under a CC-BY-4.0 license, permitting open reuse.

Limitations

• Row count is unknown, which may limit suitability assessment.
• Column-level documentation is absent; field semantics must be inferred after download.
• The dataset is very small (15.3 KB), indicating limited scope, likely containing summary or protocol data rather than extensive patient records.

Provenance

Source

figshare, authored by Shengjun Wang.

Collection Method

Data likely originates from a prospective, single-center clinical trial using a rolling-six dose-escalation design.

Time Range

The temporal coverage of the underlying trial is not specified.

Freshness

Last updated 2026-04-15 04:36:35; freshness should be verified.

Geography

The spatial coverage of the single-center trial is not specified.