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

Phase 1

Not yet recruiting

• Conditions: Intracerebral Hemorrhage; Intracranial Hemorrhages; Hemorrhagic Strokes
• Interventions: Drug: TNK

• Registration Number: NCT06696131
• Lead Sponsor: Gaurav Gupta, MD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Study Start: 2025-09-15
• Primary Completion: 2027-01-15
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TNK	TNK	Participants would be given TNK through a brain catheter to dissolve an intracerebral blood clot after a hemorrhage.

Primary Outcome Measures

Name	Time	Method
Safety Assessment	From treatment until follow-up date (+/- 30 days)	To assess the safety of 0.25 mg TNKase (single dose) administered directly into the hematoma via a soft brain catheter in patients with ICH.
Adverse Event Evaluation	From treatment until follow-up date (+/- 30 days)	To evaluate the incidence and severity of adverse events, such as rehemorrhage, infection, mortality at 30 days following the administration of TNKase.

Secondary Outcome Measures

Name	Time	Method
Radiological Assessment of the Hematoma Resolution	From treatment until follow-up date (+/- 30 days)	Using radiological imaging, we will assess the resolution of the hematoma from the brain with the end of treatment volume goal as 15 ml and compare these findings to baseline imaging obtained prior to TNKase administration