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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
TNK
DrugTNK will be delivered into the site of the intracerebral hemorrhage via a brain catheter.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: TNKExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gaurav Gupta, MD
Lead sponsor
Rutgers, The State University of New Jersey
Sponsor institution
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: