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

Primary Purpose

Hypertensive Intracerebral Hemorrhage

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

YL-1 type of intracranial hematoma puncture needle

dehydrating agent, haemostatic

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 SexesDoes not accept healthy volunteers

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

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

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.

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

NCT ID

NCT00752024

First Posted

June 9, 2008

Last Updated

September 12, 2008

Sponsor

Huazhong University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT00752024

Brief Title

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

Acronym

SATIH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

September 2010 (Anticipated)

Study Completion Date

December 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. 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.

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

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

YL-1 type of intracranial hematoma puncture needle

Other Intervention Name(s)

aspiration drainage

Intervention Description

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)

dehydrating agent, haemostatic

Other Intervention Name(s)

conservative treatment

Intervention Description

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

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

wei wang, doctor

Phone

86-027-8366-3648

daodetongji@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

zhouping tang, doctor

Phone

86--013971616328

ddjtzp@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

wei wang, doctor

Organizational Affiliation

Tongji Hospital

Official's Role

Principal Investigator

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

daodetongji@163.com

First Name & Middle Initial & Last Name & Degree

zhouping tang, doctor

Phone

86-013971616328

ddjtzp@163.com

First Name & Middle Initial & Last Name & Degree

wei wang, doctor

12. IPD Sharing Statement

Citations:

PubMed Identifier

22274965

Citation

Tang ZP, Shi YH, Yin XP, Xu JZ, Zhang SM, Wang W. Modifying the details of aspiration operation may contribute to the improvement of prognosis of patients with ICH. Turk Neurosurg. 2012;22(1):13-20. doi: 10.5137/1019-5149.JTN.4219-11.0.

Results Reference

derived

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

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