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

Primary Purpose

Hypertensive Intracerebral Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stereotactic Aspiration and Thrombolysis
conservative treatment
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Intracerebral Hemorrhage focused on measuring HICH, Suction drainages, TTAC

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stereotactic Aspiration and Thrombolysis

conservative treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The rate of rebleeding and mortality, Glasgow Outcome Scale for prognosis

Secondary Outcome Measures

Nation of Health Stroke Scale Score , modified Rankin Scale, Barthel Index complications

Full Information

First Posted
July 15, 2009
Last Updated
July 15, 2009
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00940745
Brief Title
Modified Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage:a Multi-center Controlled Study
Acronym
MSATIH
Official Title
Modified Stereotactic Aspiration and Thrombolysis of Spontaneous Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Intracerebral Hemorrhage
Keywords
HICH, Suction drainages, TTAC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Aspiration and Thrombolysis
Arm Type
Experimental
Arm Description
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.
Arm Title
conservative treatment
Arm Type
Active Comparator
Arm Description
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
Device
Intervention Name(s)
Stereotactic Aspiration and Thrombolysis
Other Intervention Name(s)
aspiration drainage
Intervention Description
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
Drug
Intervention Name(s)
conservative treatment
Other Intervention Name(s)
traditional therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: CT diagnosis of spontaneous supratentorial intracerebral hemorrhage, the amount of bleeding is more than 30 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. former GCS score > = 5 points Systolic blood pressure <= 200 mmHg, mean arterial pressure <= 150 mmHg Fasting plasma glucose <= 11.1 mmol / L Patients aged 18 to 80 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 he 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 patients with possible poor compliance or fail to be followed up Other such as pregnancy, cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhouping Tang, doctor
Phone
86-013971616328
Email
ddjtzp@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Wang, doctor
Phone
86-027-8366-3648
Email
daodetongji@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhouping Tang, doctor
Organizational Affiliation
Tongji Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wei wang, doctor
Phone
86-027-8366-3648
Email
daodetongji@163.com
First Name & Middle Initial & Last Name & Degree
zhouping tang, doctor
Phone
86-013971616328
Email
ddjtzp@163.com
First Name & Middle Initial & Last Name & Degree
wei wang, doctor

12. IPD Sharing Statement

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

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