Selective Intra-Arterial Cooling Stroke Trial Protocol and Analysis Plan

258 patients are estimated for a multicenter, randomized, controlled trial to evaluate selective intra-arterial cooling infusion as an adjunct to endovascular thrombectomy for acute ischemic stroke. The trial protocol and statistical analysis plan were authored by figshare admin karger and published on figshare in April 2026. The primary outcome is functional recovery measured by the modified Rankin Scale at 90 days.

Use Cases

• Reviewing a clinical trial protocol based on the described multicenter, randomized, controlled design
• Analyzing statistical power calculations based on the described sample size of 258 patients
• Studying outcome measures for stroke trials based on the described primary and secondary endpoints (mRS, Barthel index, infarct volume)
• Examining safety monitoring frameworks based on the described safety outcomes (intracranial hemorrhage, mortality)

Strengths

• Protocol is structured for a randomized, controlled, blinded clinical trial conducted at 12 hospitals
• Sample size calculation is explicitly detailed with 258 patients, 80% power, and a significance level of 0.05
• Outcome measures are clearly defined, including primary (mRS at 90 days) and multiple secondary endpoints

Limitations

• Row count is unknown, which may limit suitability assessment
• Column-level documentation is absent; field semantics must be inferred after download
• The 642.5 KB file size suggests the dataset is limited in scope, likely containing the protocol document rather than extensive patient data

Provenance

Source

figshare admin karger

Collection Method

Investigator-initiated and -conducted clinical trial protocol

Time Range

Trial follow-up period is 90 days; protocol published in 2026

Freshness

Last updated 2026-04 11:55:20; freshness should be verified

Geography

Conducted at 12 hospitals in China