Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage (ICH)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGaurav Gupta, MD
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TNK
Treatment groups
5 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Gaurav Gupta, MD
Lead sponsor
Rutgers, The State University of New Jersey
Sponsor institution
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov