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New treatment option for Intraventricular Hemorrhage
Official title rhTNK-tPA Thrombolytic Removal of Intraventricular Hemorrhage
ClinicalTrials.gov ID: NCT06814964
What this study is testing
What is Low dose group?
Low dose group is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for intraventricular hemorrhage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this pilot study is to determine the safety and optimal dose of clot lysis with rhTNK-tPA for intraventricular hemorrhage, using stereotactic guidance for extraventricular drain placement.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18-80 years.
- Symptom onset within 24 hours prior to diagnostic CT scan. Patients with unknown onset time should be excluded. For patients with symptoms occurring...
- Spontaneous intracerebral hemorrhage (ICH) ≤ 30 ml，with intraventricular hemorrhage (IVH) \>20 ml obstructing the third and/or fourth ventricles.
- All patients must have an external ventricular drain (EVD) placed prior to enrollment: The EVD should be accurately positioned into the largest...
- A stability CT scan performed ≥ 6 hours after EVD placement must confirm ICH clot stability: The ICH volume change should be ≤ 5 ml compared to the...
You likely can't join if
- Hemorrhage caused by aneurysms, arteriovenous malformations (AVM), tumors, or other identifiable causes. If the cause of ICH is unknown, CTA, DSA, or...
- Presence of choroid plexus vascular malformation or Moyamoya disease.
- Hypercoagulable state or coagulopathy. Patients requiring long-term anticoagulation are excluded. Reversal of anticoagulation is permitted if...
- Use of anticoagulants (e.g., dabigatran, apixaban, rivaroxaban) or antiplatelet agents (e.g., tirofiban, ticagrelor, cilostazol, clopidogrel) within...
- Platelet count \ 1.4.
- Pregnancy (positive serum or urine pregnancy test).
See the full eligibility criteria
- Age 18-80 years.
- Symptom onset within 24 hours prior to diagnostic CT scan. Patients with unknown onset time should be excluded. For patients with symptoms occurring during sleep, the time of symptom onset should be considered as the...
- Spontaneous intracerebral hemorrhage (ICH) ≤ 30 ml，with intraventricular hemorrhage (IVH) \>20 ml obstructing the third and/or fourth ventricles.
- All patients must have an external ventricular drain (EVD) placed prior to enrollment: The EVD should be accurately positioned into the largest cerebrospinal fluid (CSF) pool or the least bloody site in the lateral...
- A stability CT scan performed ≥ 6 hours after EVD placement must confirm ICH clot stability: The ICH volume change should be ≤ 5 ml compared to the previous CT scan. If the stability CT scan shows a difference \> 5 ml...
- IVH clot stability: The width of the lateral ventricle most affected by the clot must not increase by \> 2 mm. If the stability CT scan shows a difference \> 2 mm, a repeat stability CT scan should be performed ≥ 12...
- Catheter tract bleeding on the stability CT scan must be ≤ 5 ml. If any CT slice shows catheter tract bleeding \> 5 ml, a repeat stability CT scan should be performed ≥ 12 hours later. Stability CT scans may be repeated...
- On the stability CT scan, the third and/or fourth ventricles must be occluded with blood.
- Primary IVH (ICH = 0) is eligible.
- Sustained systolic blood pressure (SBP) \< 180 mmHg for at least 6 hours prior to enrollment. (Patients do not need to meet the SBP criteria throughout the screening period, but vital signs should remain stable during...
- No intraventricular thrombolytic treatment within 12 hours of symptom onset.
- Enrollment must be completed within 72 hours of the diagnostic CT scan. (The 72-hour limit may be extended with PI approval for reasons such as hematoma stability, INR stability, or other valid justifications).
- Pre-morbid modified Rankin Scale (mRS) score of 0 or 1.
- Hemorrhage caused by aneurysms, arteriovenous malformations (AVM), tumors, or other identifiable causes. If the cause of ICH is unknown, CTA, DSA, or other definitive imaging must be performed during screening to rule...
- Presence of choroid plexus vascular malformation or Moyamoya disease.
- Hypercoagulable state or coagulopathy. Patients requiring long-term anticoagulation are excluded. Reversal of anticoagulation is permitted if long-term anticoagulation is not required.
- Use of anticoagulants (e.g., dabigatran, apixaban, rivaroxaban) or antiplatelet agents (e.g., tirofiban, ticagrelor, cilostazol, clopidogrel) within one week prior to symptom onset (aspirin is allowed).
- Platelet count \ 1.4.
- Pregnancy (positive serum or urine pregnancy test).
- Infratentorial hemorrhage.
- Thalamic hemorrhage with significant midbrain extension, third nerve palsy, or dilated and non-reactive pupils. Other supranuclear gaze abnormalities are not excluded. Posterior fossa or cerebellar hemorrhages are...
- Subarachnoid hemorrhage (SAH) or any atypical hematoma location or appearance on diagnostic CT scan. Angiography (CTA, DSA, or MRA/MRI) must be performed to rule out other causes. If no source of bleeding is identified...
- Unstable ICH/IVH with ongoing hematoma enlargement.
- Indications for craniotomy: ① Progressive decline in consciousness; ② Signs of brain herniation; ③ Hematoma located \< 1 cm from the cortical surface.
- Ongoing internal bleeding involving retroperitoneal, gastrointestinal, genitourinary, or respiratory tracts. Patients with prior bleeding that is clinically stable for ≥ 12 hours and without coagulopathy or bleeding...
- Multifocal superficial bleeding at multiple vascular puncture or access sites (e.g., venipuncture, arterial puncture) or recent surgical sites.
- Any condition that, in the investigator's opinion, poses a significant risk to the patient or makes the patient unsuitable for the study.
- Planned or concurrent participation in another treatment clinical trial. Participation in observational, natural history, or epidemiological studies without intervention is allowed.
- Inability to obtain informed consent from the patient or legal representative.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.