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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 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:
NCT00940745
First received: July 15, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  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

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: 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
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.
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

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
Criteria

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
  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: NCT00940745

Contacts
Contact: Zhouping Tang, doctor 86-013971616328 ddjtzp@163.com
Contact: Wei Wang, doctor 86-027-8366-3648 daodetongji@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
Study Director: Zhouping Tang, doctor Tongji hospital, Tongji Medical College, 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
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 August 28, 2014