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

NCT ID: NCT00940745

Last Updated: 2009-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-03-31

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.

Conditions

Hypertensive Intracerebral Hemorrhage

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stereotactic Aspiration and Thrombolysis

To position haematoma's location, drills several 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.

Group Type: EXPERIMENTAL

Stereotactic Aspiration and Thrombolysis

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

conservative treatment

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Other Intervention Names

aspiration drainage; traditional therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Department of Neurology of Tongji Hospital, Huazhong University of Sci. and Tec.

Principal Investigators

Zhouping Tang, doctor

Role: STUDY_DIRECTOR

Tongji Hospital

Locations

Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

Central Contacts

Zhouping Tang, doctor

Role: CONTACT

ddjtzp@163.com

86-013971616328

Wei Wang, doctor

Role: CONTACT

daodetongji@163.com

86-027-8366-3648

Facility Contacts

wei wang, doctor

Role: primary

daodetongji@163.com

86-027-8366-3648

zhouping tang, doctor

Role: backup

ddjtzp@163.com

86-013971616328

Other Identifiers

2009JX4A03

Identifier Type: -

Identifier Source: org_study_id