Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage (ICH) (NCT06696131) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage (ICH)
5 participantsStarted 2026-09-15
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Patient/legally authorized representative has signed the Informed Consent Form.
* Ability to comply with the study protocol, in the investigator's judgment.
* Patients 18 to 80 years of age with an ICH had occurred within 24 hours before admission.
* Spontaneous supratentorial (basal ganglia, thalamus, lobar) ICH ≥30 mL measured utilizing the ABC/2 method.
* Subjects with a GCS score of 5-14.
* NIHSS ≥6.
* Stability CT scan done at least 6 hours after baseline CT showing clot stability (growth \<5 mL as measured by ABC/2 method). If the hematoma volume measured on the stability CT scan increases by 5 mL or more, a second stability CT scan will be performed 12 hours later.
* Sustained systolic blood pressure (SBP) \<180 mm Hg for six hours recorded closest to the time of drug administration.
* Symptoms must be present less than 24 hours prior to baseline CT scan.
* Baseline Rankin score of 0 or 1.
Exclusion Criteria
* Presence of infratentorial parenchymal bleeding.
* Presence of a hemorrhage extending to the midbrain.
* An unknown time of onset or the symptoms onset more than 24 hours prior to admission.
* Pregnancy.
* Inability to obtain written informed consent from subject or legal representative.
* Sustained SBP \>180 mm Hg for six hours recorded closest to the time of drug administration.
* Age \<18 and \>80 years.
* Radiological evidence of arterio-venous malformation, aneurysm, amyloid angiopathy, Moyamoya disease, hemorrhagic conversion of an i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety Assessment
Timeframe: From treatment until follow-up date (+/- 30 days)
2
Adverse Event Evaluation
Timeframe: From treatment until follow-up date (+/- 30 days)