Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage: a Prospective Controlled Study (SATIH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Huazhong University of Science and Technology.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00752024
First received: June 9, 2008
Last updated: September 12, 2008
Last verified: September 2008
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage: a Prospective Controlled Study(SATIH)

Resource links provided by NLM:


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
Experimental: 1
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.

Other Name: aspiration drainage
Active Comparator: 2
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.
Other Name: conservative 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Not yet recruiting
Wuhan, Hubei, China, 430030
Contact: wei wang, doctor    86-027-8366-3648    daodetongji@163.com   
Contact: zhouping tang, doctor    86-013971616328    ddjtzp@163.com   
Principal Investigator: wei wang, doctor         
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

No publications provided by Huazhong University of Science and Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wei Wang and Zhouping Tang, Department of Neurology of Tongji Hospital, Huazhong University of Sci. and Tec.
ClinicalTrials.gov Identifier: NCT00752024     History of Changes
Other Study ID Numbers: 2006AA301B50-1
Study First Received: June 9, 2008
Last Updated: September 12, 2008
Health Authority: China: Ethics Committee

Keywords provided by Huazhong University of Science and Technology:
HICH
Suction drainages
TTAC

Additional relevant MeSH terms:
Cerebral Hemorrhage
Hemorrhage
Intracranial Hemorrhage, Hypertensive
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Hemostatics
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014