Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage: a Prospective Controlled Study - Full Text View

Sponsored by:	Huazhong University of Science and Technology
Information provided by:	Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00752024

Purpose

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.

Condition	Intervention
Hypertensive Intracerebral Hemorrhage	Device: YL-1 type of intracranial hematoma puncture needle Drug: dehydrating agent, haemostatic

Drug Information available for: Calcium carbonate Aminocaproic acid 6-Aminocaproic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Investigator), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage: a Prospective Controlled Study（SATIH）

Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:

The rate of rebleeding and mortality, Glasgow Outcome Scale for prognosis [ Time Frame: duration of 14 days after operation(rebleeding), duration of hospital stay(mortality), 180 days after onset(mortality and GOS) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Nation of Health Stroke Scale Score , modified Rankin Scale, Barthel Index complications [ Time Frame: 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.	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.
2: Active Comparator 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.	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.

Arms

Assigned Interventions

1: Experimental

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.

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.

2: Active Comparator

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.

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.

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.

We 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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

CT diagnosis of spontaneous supratentorial intracerebral hemorrhage, the amount of bleeding more than 50 ml, and had neurological signs
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
To be random, former GCS score > = 5 points
Systolic blood pressure <= 200 mmHg, mean arterial pressure <= 150 mmHg (if higher than this value, but as corresponding to this standard can be dealt with the group, and only reached the standard before they can ask for random)
Fasting plasma glucose <= 11.1 mmol / L (if higher than this value, but as corresponding to this standard can be dealt with the group, and only reached the standard before they can ask for random)
Patients aged 18 to 80-year-old.
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.
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:

Patients clotting mechanisms are obstacles or having the experience of the use of anticoagulant drug (PT> 15s, APTT> 40s, INR> 1.4, platelet count <100 × 10 9 / L).
Cerebral hernia formed more than two hours
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
A clear cause of cerebral hemorrhage such as intracranial aneurysm, or dynamic
such as a venous malformation
Intracranial or serious systemic infection
Marked cognitive impairment or mental abnormality
Other such as pregnancy, cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752024

Contacts

Contact: wei wang, doctor	86-027-8366-3648	daodetongji@163.com
Contact: zhouping tang, doctor	86--013971616328	ddjtzp@163.com

Locations

China, Hubei
Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030

Sponsors and Collaborators

Huazhong University of Science and Technology

Investigators

Principal Investigator:

wei wang, doctor

Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

More Information

Responsible Party:	Department of Neurology of Tongji Hospital, Huazhong University of Sci. and Tec. ( Wei Wang and Zhouping Tang )
Study ID Numbers:	2006AA301B50-1
Study First Received:	June 9, 2008
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00752024
Health Authority:	China: Ethics Committee

Keywords provided by Huazhong University of Science and Technology:

HICH
Suction drainages
TTAC
Suction drainages

Study placed in the following topic categories:

Cerebral Hemorrhage
Vascular Diseases
Central Nervous System Diseases
Calcium Carbonate
Intracranial Hemorrhage, Hypertensive

Intracranial Hemorrhages
Brain Diseases
Hemorrhage
6-Aminocaproic Acid
Cerebrovascular Disorders

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009