Modified Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage:a Multi-center Controlled Study (MSATIH)
Recruitment status was Not yet recruiting
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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: Stereotactic Aspiration and Thrombolysis Drug: conservative treatment |
| 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: | Modified Stereotactic Aspiration and Thrombolysis of Spontaneous Intracerebral Hemorrhage |
- 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 ]
- 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: | 400 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Device: 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. Other Name: aspiration drainage
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Active Comparator: 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.
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Drug: 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.
Other Name: traditional therapy
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Zhouping Tang, doctor | 86-013971616328 | ddjtzp@163.com |
| Contact: Wei Wang, doctor | 86-027-8366-3648 | daodetongji@163.com |
| 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 | |
| Study Director: | Zhouping Tang, doctor | Huazhong University of Science and Technology |
More Information
No publications provided
| Responsible Party: | Zhouping Tang, Department of Neurology of Tongji Hospital, Huazhong University of Sci. and Tec. |
| ClinicalTrials.gov Identifier: | NCT00940745 History of Changes |
| Other Study ID Numbers: | 2009JX4A03 |
| Study First Received: | July 15, 2009 |
| Last Updated: | July 15, 2009 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Huazhong University of Science and Technology:
|
HICH Suction drainages TTAC |
Additional relevant MeSH terms:
|
Hemorrhage Intracranial Hemorrhage, Hypertensive Cerebral Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases 6-Aminocaproic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013