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NCT06696131 | NOT YET RECRUITING | Intracerebral Hemorrhage

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

Gaurav Gupta, MD

Information provided by (Responsible Party):

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.

Condition or disease

Intracerebral Hemorrhage

Intracranial Hemorrhages

Hemorrhagic Strokes

Intervention/treatment

TNK

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 5 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage(ICH)
Actual Study Start Date : 2025-01-15
Estimated Primary Completion Date : 2027-01-15
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • Patients 18 to 80 years of age with an Intracerebral Hemorrhage (ICH) had occurred within 24 hours before admission.
  • Spontaneous supratentorial (basal ganglia, thalamus, lobar hemorrhage) ICH ≥30 mL measured utilizing ABC/2 method.
  • GCS ≤14 or a 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 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, 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.
  • Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.
  • Bilateral fixed, dilated pupils indicating irreversible impaired brain stem function with GCS ≤4.
  • 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).
  • Internal bleeding (GI, renal, respiratory etc). Mechanical heart valve. Allergy or sensitivity to TNK. 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.
Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage(ICH)

Location Details

NCT06696131

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