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RECRUITING
NCT06814964
PHASE1

rhTNK-tPA Thrombolytic Removal of Intraventricular Hemorrhage

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2025-03-01

Completion Date

2025-06-01

Last Updated

2025-02-27

Healthy Volunteers

No

Interventions

DRUG

Low 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.

DRUG

Medium 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.

DRUG

High 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.

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China