NCT00365248: TachoSil for bleeding in pediatric liver surgery

NCT00365248 evaluated TachoSil as an adjunct to control local bleeding during pediatric liver resection, including surgery involving segmental liver transplantation. The phase IIIb study was prospective, multicenter, open-label and single-arm. It enrolled 16 children, rather than the larger sample originally intended. 1 2

In the original report by Mirza and colleagues, satisfactory hemostasis was achieved in 13 of 16 children within three minutes: 81.3%, with a reported 95% confidence interval of 61.8%–100%. One additional child achieved hemostasis by eight minutes. These are observed surgical outcomes, not merely protocol targets. 2

The result supports the feasibility of applying this hemostatic patch in the studied pediatric operations. However, the small uncontrolled design does not quantify an advantage over another technique, and the broad confidence interval reflects limited precision. Larger adult TachoSil trial results are not substitutes for this pediatric population. 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00365248. Original registration; establishes the exact study identity and registered methods.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00365248. Original registration; establishes the exact study identity and registered methods.

2. PubMed — Mirza et al. (2011). Original pediatric TachoSil liver-surgery report, PMID 21494994. Supports actual enrollment and the three- and eight-minute hemostasis findings.Research publication · Publication abstract read via Europe PMC; identifier and title cross-checked. Checked 2026-10-10. Full paper was not independently re-read for this update; abstract details should not be extended beyond what it reports.