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Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage

NCT07208097 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 768

Last updated 2025-12-01

No results posted yet for this study

Summary

This is an phase III prospective, multi-center, open-label, randomized controlled trial (RCT) with blinded endpoint assessment. It plans to enroll 768 subjects with spontaneous supratentorial intracerebral hemorrhage, who will be randomly assigned in a 1:1 ratio to the investigational arm (stereotactic minimally invasive puncture for intracerebral hemorrhage combined with TNK liquefaction drainage, single TNK dose of 0.5mg per time or the standard medical treatment group.

Conditions

  • Intracerebral Haemorrhage
  • Minimally Invasive Treatment

Interventions

PROCEDURE

Stereotactic thrombolysis with Tenecteplase

Stereotactic thrombolysis with Tenecteplase for ICH is a minimally invasive method for evacuation hematoma. The hematoma puncture target is identified via CT imaging before surgery. After local anesthesia and sedation, stereotactic minimally invasive surgery is performed with the Leksell stereotactic frame. A postoperative CT scan is immediately conducted to confirm the absence of intracranial rebleeding before administering tenecteplase into the hematoma. Tenecteplase is fully diluted in 2 mL of saline and injected into the hematoma cavity via an irrigation catheter. The drainage tube is clamped for 1 hour before opening (early opening is permitted if necessary). The single dose of TNK is 0.5 mg and can be administered with a maximum of 2 dose in every 24 hours. The target hematoma clearance criteria is: residual hematoma volume ≤10 mL or ≤20% of the initial volume.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-10-25
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • China

Study Locations

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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 NCT07208097 on ClinicalTrials.gov