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Minimally Invasive Surgery and RhTNK-tPA for Intracerebral Hemorrhage Evacuation

NCT06668441 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-03-07

No results posted yet for this study

Summary

The purpose of this trial is to determine the safety of using a combination of robot-assisted stereotactic puncture and clot lysis with rhTNK-tPA to remove intracerebral hemorrhage (ICH) and to provide dose evidence for a phase III clinical trial.

Conditions

  • Intracranial Hemorrhages
  • Cerebrovascular Disorders
  • Cerebral Hemorrhage
  • Hemorrhage

Interventions

DRUG

Minimally invasive surgery plus low-dose rhTNK-tPA group

The calculated injection amount of teneplase (teneplase injection amount = volume of hematoma ×0.001mg) was diluted to 1ml with sterile injection water, and injected into the stereotaxically planned puncture path according to the location and size of the hematoma. The pipeline was rinsed with 0.5ml normal saline, and the drainage tube was fixed and closed for 2 hours, so that after the full effect of the drug on the hematoma mass was ensured. Re-open the drain to allow gravity drainage.

DRUG

Minimally invasive surgery plus medium dose rhTNK-tPA group

The calculated injection amount of teneplase (teneplase injection amount = volume of hematoma ×0.003mg) was diluted to 1ml with sterile injection water, and injected into the stereotaxically planned puncture path according to the location and size of the hematoma. The pipeline was rinsed with 0.5ml normal saline, and the drainage tube was fixed and closed for 2 hours, so that after the full effect of the drug on the hematoma mass was ensured. Re-open the drain to allow gravity drainage.

DRUG

Minimally invasive surgery plus high dose rhTNK-tPA group

The calculated injection amount of teneplase (teneplase injection amount = volume of hematoma ×0.009mg) was diluted to 1ml with sterile injection water, and injected into the stereotaxically planned puncture path according to the location and size of the hematoma. The pipeline was rinsed with 0.5ml normal saline, and the drainage tube was fixed and closed for 2 hours, so that after the full effect of the drug on the hematoma mass was ensured. Re-open the drain to allow gravity drainage.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Yong Cao, MD · Beijing Tiantan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2025-01-27
Completion
2025-01-27

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06668441 on ClinicalTrials.gov