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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
TNK will be delivered into the site of the intracerebral hemorrhage via a brain catheter.
Safety Assessment
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.
Time frame: From treatment until follow-up date (+/- 30 days)
Adverse Event Evaluation
To evaluate the incidence and severity of adverse events, such as rehemorrhage, infection, mortality at 30 days following the administration of TNKase.
Time frame: From treatment until follow-up date (+/- 30 days)
Radiological Assessment of the Hematoma Resolution
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
Time frame: From treatment until follow-up date (+/- 30 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.