Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage (ICH)

Sponsor
Gaurav Gupta, MD
Study ID
NCT06696131
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Hemorrhagic Strokes
  • Intracerebral Hemorrhage
  • Intracranial Hemorrhages

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • TNK — DRUG
    TNK will be delivered into the site of the intracerebral hemorrhage via a brain catheter.

Study Details

The overall purpose of this study is to look at the safety and effectiveness of administering Tenecteplase (TNK) into the brain bleed (hematoma) instead of another clot-dissolving drug known as recombinant tissue plasminogen activator (rtPA), which is the current standard practice. Clot dissolving (Fibrinolytic) drugs work to break down blood clots and have been found to improve health outcomes when applied directly into the hematoma within the brain. Patients who take part in this study will undergo the same surgical procedure that would normally be performed to treat them, but with the exception of TNK not rtPA.

Key Dates

First listed
Nov 20, 2024
Start date
Sep 15, 2026
Status verified
Apr 2026
Primary completion
Jan 15, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TNK
    Participants would be given TNK through a brain catheter to dissolve an intracerebral blood clot after a hemorrhage.

Primary Outcome Measure

Safety Assessment [ Time Frame: From treatment until follow-up date (+/- 30 days) ]

Central Contacts

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