Clinical trial NCT00940745: Modified Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage:a Multi-center Controlled Study
Official title: Modified Stereotactic Aspiration and Thrombolysis of Spontaneous Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertensive Intracerebral Hemorrhage
Keywords: HICH
Suction drainages
TTAC
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2009-07-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the superiority of effect of the modified micro-invasive aspiration and drainage and conservative medical therapy in the treatment of ICH spontaneously hypertensive scientifically.

Detailed description: The stereotactic computed tomographic-guided aspiration and drainage is one of the best choices in the treatment of a large-scale deep supratentorial intracerebral hematoma. It uses hardware access technology, in a relatively short time to enter the hematoma center, with suction liquefaction technology. It has the advantage of a higher clearance rate of the hematoma, simple convenience, small trauma and low-cost. We carry on the suitable improvement in this technology's foundation in view of its deficiency, the introduction of the concept of the individual, will further reduce the rate of bleeding and mortality, improve survival, such as long-term quality of life.

The investigators will adopt scales such as the rate of rebleeding, mortality, complication,NIHSS, MRS, BI, GOS scale to analysis and evaluating efficacy and safety of this technology and conservative treatment in the treatment of HICH.

Eligibility criteria: Inclusion Criteria:

1. CT diagnosis of spontaneous supratentorial intracerebral hemorrhage, the amount of bleeding is more than 30 ml, and had neurological signs.
2. All income groups the incidence of medical records to be random, the time should be \< 69 hours to ensure that within 72 hours of the onset of the operation.
3. former GCS score \> = 5 points
4. Systolic blood pressure \<= 200 mmHg, mean arterial pressure \<= 150 mmHg
5. Fasting plasma glucose \<= 11.1 mmol / L
6. Patients aged 18 to 80
7. Based on China's relevant laws, the patient himself or family members (only in patients with the loss of his ability to judge the acts of circumstances) agreed to participate in this study, a good compliance, to fully comply with random, in accordance with the decision by the treatment, patients himself Or family members must sign informed consent moreover.
8. Patients themselves or their families (only in patients with the loss of his ability to judge the acts of circumstances) have willingness and ability to follow the research program, data collection and preservation of history and follow-up process of informed consent.

Exclusion Criteria:

1. Patients clotting mechanisms are obstacles or having the experience of he use of anticoagulant drug (PT\> 15s, APTT\> 40s, INR\> 1.4, platelet count \<100 × 10 9 / L).
2. Cerebral hernia formed more than two hours
3. The merger of other serious system failure (heart, liver and kidney, etc.) or a variety of end-stage disease with cerebral hematoma (such as renal failure late cerebral hemorrhage, blood disease with cerebral hemorrhage) Prior to the onset of a variety of reasons for the defect or neurological movement disorder
4. A clear cause of cerebral hemorrhage such as intracranial aneurysm, or dynamic
5. such as a venous malformation
6. Intracranial or serious systemic infection
7. Marked cognitive impairment or mental abnormality
8. patients with possible poor compliance or fail to be followed up
9. Other such as pregnancy, cancer

Primary outcomes:
measure: The rate of rebleeding and mortality, Glasgow Outcome Scale for prognosis
timeFrame: duration of 14 days after operation(rebleeding), duration of hospital stay(mortality), 180 days after onset(mortality and GOS)
Secondary outcomes:
measure: Nation of Health Stroke Scale Score , modified Rankin Scale, Barthel Index complications
timeFrame: the moment of admission and post operation(NIHSS), 14 days after admission(NIHSS,MRS), duration of hospital stay(complications), 180 days after onset(BI, MRS)
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Zhouping Tang, doctor
role: STUDY_DIRECTOR
References: