New drug injection aims to dissolve brain bleeds safely
NCT ID NCT06696131
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether a drug called Tenecteplase (TNK) is safe to inject directly into a brain bleed (intracerebral hemorrhage). Five adults aged 18-80 with large bleeds will receive a single dose during standard surgery. The goal is to see if TNK can dissolve the clot without causing more bleeding or other serious side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ischemic stroke, recurrent hemorrhage in the same location within the past 365 year or unstable mass as a source for the ICH. * Evidence of coagulopathy (international normalized ratio \>1.3; platelet count \<100 ,000 or platelet dysfunction P2Y-12 \>250) or known clotting disorder. * Bilateral fixed, dilated pupils indicating irreversible impaired brain stem function with GCS ≤4. * Patients with severe ICH and IVH who require an external ventricular drain (EVD) placement for cerebrospinal fluid (CSF) diversion or separate intraventricular thrombolysis. * Inability to maintain INR less than 1.3. * Use of anticoagulants prior to symptom onset and subjects requiring long-term anticoagulants (the reversal is permitted if the patient can tolerate the short-term risk of reversal). * Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset. * Internal bleeding (GI, renal, respiratory etc). * Mechanical heart valve (Bioprosthetic heart valve is permitted). * Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis (atrial fibrillation without mitral stenosis is permitted). * Allergy or sensitivity to TNKase. * Participation in a concurrent clinical trial. * Serious illness (advanced stage which can interfere with the outcome). * The patient is unstable and would not benefit from a surgical intervention. * GCS score of 3-4 and 15 (to ensure patient safety and study feasibility). * Historical mRS score of 2-6 (at admission). * Symptomatic tract hemorrhage or a tract hemorrhage more than 5 mm.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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