RecruitingPhase 1NCT06814964

rhTNK-tPA Thrombolytic Removal of Intraventricular Hemorrhage

A Phase I Pilot Clinical Trial of Dose Escalation With Stereotactic-Guided Intraventricular Thrombolysis Using Tenecteplase (rhTNK-tPA) for Intraventricular Hemorrhage.

Sponsor

Beijing Tiantan Hospital

Enrollment

18 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Intraventricular hemorrhage

Summary

The purpose of this pilot study is to determine the safety and optimal dose of clot lysis with rhTNK-tPA for intraventricular hemorrhage, using stereotactic guidance for extraventricular drain placement.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called High dose group, a drug called Low dose group, and others for people with intraventricular hemorrhage. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow dose group

The calculated injection amount of tenecteplase (tenecteplase injection amount = volume of intraventricular hematoma × 0.009 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD.

DRUGMedium dose group

The calculated injection amount of tenecteplase (tenecteplase injection amount = volume of intraventricular hematoma × 0.018 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD.

DRUGHigh dose group

The calculated injection amount of tenecteplase (tenecteplase injection amount = volume of intraventricular hematoma × 0.027 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD.