Ventricular hemorrhage
Conditions
Interventions
experimental group:simultaneous intraventricular and intrathecal injection of rt-PA
control group:simultaneous intraventricular and intrathecal injection of saline
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Those who meet all the following criteria are included: 1. Male or female aged 18-75; 2. Clinical symptoms of cerebral hemorrhage within 24 hours before diagnostic CT scan, including headache, nausea, vomiting, varying degrees of disturbance of consciousness and limb paralysis; 3. Spontaneous intracerebral hemorrhage less than or equal to 30cc, or ventricular hemorrhage blocking the third and/or fourth ventricles; 4. Stable ICH clot size 6 hours or more after IVC placement: ICH must be no more than 30cc at the first appearance and no more than 35cc at the scan for clot stability prior to subsequent randomization. CT scan results must be stable (difference =5cc) 6 hours or more after inferior vena cava insertion when compared to the CT scan results determined by the earliest (AxBxC)/2 method. 5. Blood clot stability of IVH 6 hours or longer after IVC placement: The lateral ventricle width, which was most affected by blood clots, did not increase. 2 mm to ensure blood movement under gravity. 6. Catheter bleeding is stable 6 hours or more after IVC placement: CT scan indicates it must be less than or equal to 5cc. 7. On a stable CT scan, the 3rd and/or 4th ventricles were obstructed by blood. 8. External ventricular drainage tube (EVD) was placed according to neurosurgical intensive care criteria. 9. Patients with primary ventricular hemorrhage met the requirements (ICH=0); 10. SBP was consistently below 200 mmHg, 6 hours before administration (after randomization) 11. Do not use the test product until at least 12 hours after the onset of symptoms. 12. Can be randomized within 72 hours of diagnosis of IVH by CT scan (provided that the time between symptom onset and diagnosis of CT is less than 24 hours). 13. Previous mRS 0 or 1. 14. GCS 5-13 .
Exclusion criteria
Exclusion criteria: Any one of the following situations is excluded: 1. Suspected (unless ruled out by angiography or MRA/MRI) or untreated ruptured cerebral aneurysms, intracranial arteriovenous malformations (intracranial AVMs), or intracranial tumors. Treatment of existing aneurysms or AVMs must be performed at least 3 months before the current onset of disease. 2. Presence of choroidal plexus vascular malformation or moyamoya disease. 3. Coagulation disorders, and subjects requiring long-term anticoagulation. 4. Use dabigatran, Apixaban, and/or rivaroxaban (or drugs in the same drug class) before symptom onset. 5. Platelet count 1.4, APTT is lower than LLN, or higher than UPL. 6. Pregnancy (positive serum or urine pregnancy test). 7. Subatentorial bleeding. 8. Thalamic hemorrhage with significant midbrain extension, third nerve palsy, or pupillary dilation (bilateral pupillary =4mm) and no response. Other (supra-nuclear) gaze abnormalities are not excluded. Note: Patients with posterior fossa ICH or cerebellar hematoma are not eligible. 9. Subarachnoid hemorrhage (SAH) with clinical manifestations (angiography, CTA, MRA/MRI) must be obtained when a diagnostic CT scan shows that the location or appearance of SAH or any hematoma is not strongly associated with hypertension). 10. ICH/IVH enlargement that is not stable within the treatment time window. 11. Persistent internal bleeding involving retroperitoneum, or gastrointestinal, genitourinary, or respiratory tract. (Patients with a history of bleeding who were clinically stable for more than 12 hours without any coagulopathy or bleeding disorder were included.) 12. Multiple focal superficial bleeding was observed at multiple vessel puncture and indwelling sites (e.g., vein dissection, arterial puncture) or at the site of recent surgery. 13. Previously enrolled in this study. 14. Any other conditions that the investigator considers to pose a significant risk to the subject if exploratory treatment is initiated. Subjects who were not expected to survive to 180 days of follow-up due to concomitant disease and/or were in DNR/DNI (no resuscitation/intubation) signatory prior to randomization were excluded. 15. Contraindications of ventricle drainage and lumbar cistern drainage. 16. Plan or participate simultaneously (between screening and day 30) in another interventional medicine investigation or clinical trial. (Patients participating in observational, natural history, and/or epidemiological studies that do not involve treatment are eligible.) 17. There is no written informed consent signed by the subject or legal representative.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood clot clearance;Hydrocephalus incidence;Adverse event rate;Duration and level of intensive care;Improvement in neurological function from baseline;Vital signs;Laboratory examination;12 lead EKG;Improvement in quality of life from baseline;All-cause mortality;Intracranial infection rate;Incidence of craniocerebral hemorrhage;mRS scale; | — |
Countries
China
Contacts
Public ContactXingen Zhu
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed