Last updated: November 16, 2021
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Hemorrhage
Treatment
N/AClinical Study ID
NCT03957707
2018-222
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of spontaneous basal ganglia hemorrhage by imaging (CT, CTA, etc.) with avolume < 30 mL calculated by ABC/2 formula and Glasgow Coma Scale score ≥ 9.
- With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegiclimb muscle strength ≤ grade 3 or NIHSS score ≥ 15 points.
- Hematoma stability shown by a CT scan at least 6 hours after the diagnostic CT (hematoma volume increase < 5 ml by ABC/2 formula)
- Diagnostic CT scan should be obtained within 24 hours after the onset of symptoms.Cases with unclear onset time should be excluded.
- Randomization within 72 hours after diagnostic CT.
- Surgery should be performed within 72 hours after onset.
- SBP <180 mmHg maintained for 6 hours prior to randomization.
- Age between 18-70 years old.
- mRS score ≤ 1 in past medical history.
- Patients who are suitable and willing to be randomized to "puncture aspiration +urokinase" or conservative medical treatment.
Exclusion
Exclusion Criteria:
- Hematoma involves other structures such as the thalamus and midbrain.
- Mass effect or hydrocephalus due to intraventricular hemorrhage.
- Imaging-based diagnosis of cerebrovascular abnormalities such as ruptured aneurysm,arteriovenous malformation (AVM) and moyamoya disease as well as hemorrhagictransformation of ischemic infarct and recent recurrence (within 1 year) of cerebralhemorrhage.
- Manifestation of early stage cerebral herniation such as ipsilateral pupil changes andmidline shift exceeding 1 cm.
- Patients with unsteady hematoma or with progression to intracranial hypertensionsyndrome.
- Patients with any irreversible coagulopathy or known coagulation disorders; plateletcount <100,000; INR > 1.4.
- Patients requiring long-term use of anticoagulants.
- Patients taking dabigatran, apixaban and/or rivaroxaban (or similar drugs of the samecategory) before symptoms arise.
- Bleeding in other sites, including retroperitoneal, gastrointestinal, genitourinary orrespiratory tract bleeding; superficial or skin surface bleeding mainly occurring inthe vascular puncture site or transvenous approach (eg. arterial puncture, venousincision, etc. ) or in the recent surgical site.
- May be pregnant in the near future or already pregnant.
- Previously enrolled in this study.
- Participating in other interventional medical research or clinical trials at the sametime. Patients enrolled in observational, natural history and/or epidemiological studies (without intervention) are eligible for this trial.
- Patients with an expected survival of less than 6 months.
- Patients with severe co-morbidity (including hepatic, renal, gastrointestinal,respiratory, cardiovascular, endocrine, immune and/or hematological disorders) whichmay affect the outcome assessment.
- Patients with mechanical heart valve. Biological valves are acceptable.
- Patients with risk of embolism (including a history of left heart thrombus, mitralstenosis with atrial fibrillation, acute pericarditis or subacute bacterialendocarditis). Atrial fibrillation without mitral stenosis is acceptable.
- Investigators believe co-morbidities would be detrimental to the patient when thestudy begins.
- Patients difficult to follow up or with poor compliance due to various reasons (suchas geographical and social factors, drug or alcohol abuse, etc.)
- Patient or his or her legal guardian/representative is unable or unwilling to give thewritten informed consent.
- Patients is in a condition that is not suitable for "puncture aspiration + urokinase"treatment.
Study Design
Total Participants: 360
Study Start date:
January 01, 2019
Estimated Completion Date:
December 31, 2021
Connect with a study center
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting
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