Actively Recruiting

Phase 1
Age: 18Years - 80Years
All Genders
NCT06814964

rhTNK-tPA Thrombolytic Removal of Intraventricular Hemorrhage

Led by Beijing Tiantan Hospital · Updated on 2025-02-27

18

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

rhTNK-tPA Thrombolytic Removal of Intraventricular Hemorrhage

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-80 years
  • Symptom onset within 24 hours before diagnostic CT scan; unknown onset time excluded
  • Spontaneous intracerebral hemorrhage (ICH) 64 30 ml with intraventricular hemorrhage (IVH) > 20 ml blocking third and/or fourth ventricles
  • External ventricular drain (EVD) placed using robotic stereotactic guidance into largest CSF pool or least bloody lateral ventricle site
  • Stability CT scan 65 6 hours after EVD placement showing ICH volume change 64 5 ml; repeated scans allowed if needed
  • IVH clot stability with lateral ventricle width change 64 2 mm confirmed by stability CT scans
  • Catheter tract bleeding 64 5 ml on stability CT scans; total hematoma volume along tract 64 10 ml
  • Third and/or fourth ventricles occluded with blood on stability CT
  • Primary IVH with no ICH (ICH = 0) eligible
  • Sustained systolic blood pressure < 180 mmHg for at least 6 hours before enrollment
  • No intraventricular thrombolytic treatment within 12 hours of symptom onset
  • Enrollment completed within 72 hours of diagnostic CT scan (may extend with approval)
  • Pre-morbid modified Rankin Scale score of 0 or 1
Not Eligible

You will not qualify if you...

  • Hemorrhage caused by aneurysms, arteriovenous malformations, tumors, or other identifiable causes unless ruled out by imaging
  • Presence of choroid plexus vascular malformation or Moyamoya disease
  • Hypercoagulable state or coagulopathy; long-term anticoagulation excluded
  • Use of anticoagulants or antiplatelet agents (except aspirin) within one week before symptom onset
  • Platelet count < 100,000 or INR > 1.4
  • Pregnancy
  • Infratentorial hemorrhage
  • Thalamic hemorrhage with midbrain involvement or severe nerve palsy
  • Subarachnoid hemorrhage or atypical hematoma locations unless no bleeding source identified
  • Unstable ICH/IVH with ongoing hematoma growth
  • Indications for craniotomy such as brain herniation signs or superficial hematoma
  • Ongoing internal bleeding in major organ systems unless stable for 65 12 hours
  • Multiple superficial bleedings at vascular puncture or surgical sites
  • Conditions posing significant risk or unsuitability as judged by investigator
  • Participation in other interventional clinical trials
  • Inability to obtain informed consent from patient or legal representative

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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Research Team

Y

Yong Cao

CONTACT

S

Shaozhi Zhao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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