Modified Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage:a Multi-center Controlled Study

Hypertensive Intracerebral Hemorrhage Clinical Trial

— MSATIH  

Official title:

Modified Stereotactic Aspiration and Thrombolysis of Spontaneous Intracerebral Hemorrhage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00940745
• Other study ID #: 2009JX4A03
• Status: Not yet recruiting
• Phase: N/A
• First received: July 15, 2009
• Last updated: July 15, 2009
• Start date: July 2009
• Est. completion date: March 2010

Study information

• Verified date: July 2009
• Source: Huazhong University of Science and Technology
• Contact: Zhouping Tang, doctor
• Phone: 86-013971616328
• Email: ddjtzp[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hypertensive Intracerebral Hemorrhage
• Intracranial Hemorrhage, Hypertensive

Intervention

Device:
• Stereotactic Aspiration and Thrombolysis
Device: YL-1 type of intracranial hematoma puncture needle YL-1 type of intracranial hematoma puncture needle(Pat. NO.is ZL:93244252•8) was originated by Beijing WanTeFu Medical Apparatus Co.Ltd in 1997. With integration of needle and bur drill it is designed as hard tunnel.By the technique of skull self-holding, the puncture needle can being fixed in the target of haematoma for several days.This technique is convenient, simple and safe. To position haematoma's location, drills 3 millimeter holes in the localization point of puncture, then insert the drainage tube to inhale haematoma, gives the filament resolver interrupted for liquefication drainage afterward.

Drug:
• conservative treatment
dehydrating agent, haemostatic In the treatment, under the convention we use the dehydrator for patients, the ultra early patient may use anti-filament medicinal preparation 6- amino-caproic acid 6-12g/d, intravenous drip, the period of revolution does not surpass for 24 hours, then just right for the illness treatment.

Locations

Country	Name	City	State
China	Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of rebleeding and mortality, Glasgow Outcome Scale for prognosis		duration of 14 days after operation(rebleeding), duration of hospital stay(mortality), 180 days after onset(mortality and GOS)	Yes
Secondary	Nation of Health Stroke Scale Score , modified Rankin Scale, Barthel Index complications		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)	Yes