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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00752024
Acronym
SATIH
Enrollment
60
Registered
2008-09-15
Start date
2008-09-30
Completion date
2010-12-31
Last updated
2008-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive Intracerebral Hemorrhage

Keywords

HICH, Suction drainages, TTAC

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.

Interventions

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.

DRUGdehydrating 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.

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The rate of rebleeding and mortality, Glasgow Outcome Scale for prognosisduration of 14 days after operation(rebleeding), duration of hospital stay(mortality), 180 days after onset(mortality and GOS)

Secondary

MeasureTime frame
Nation of Health Stroke Scale Score , modified Rankin Scale, Barthel Index complicationsthe moment of admission and post operation(NIHSS), 14 days after admission(NIHSS,MRS), duration of hospital stay(complications), 180 days after onset(BI, MRS)

Countries

China

Contacts

Primary Contactwei wang, doctor
daodetongji@163.com86-027-8366-3648
Backup Contactzhouping tang, doctor
ddjtzp@163.com86--013971616328

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026